142 Posti di lavoro per Posizione di regulatory affairs in Monza

Drug Product Development Proposal Specialist

Monza, Lombardia Thermo Fisher Scientific

Ieri

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**As a Drug Product Development Proposal Specialist you will**:

- Initiate local quotation activities once site selection has been confirmed.
- Review technical strategy from SMEs ensuring alignment with customers needs. Dialogue with SME for alternative solutions or scope when appropriate.
- Responsible for building the draft technical scope, high level timelines and price estimates for the bid proposal using current quoting processes, tools and templates.
- Where appropriate, working with the Legal / Contracts function to ensure that the accurate legal terms and conditions are applied to a given proposal.
- Ensuring that the appropriate proposal review and authorization have been acquired from site SMEs and management; this may include supporting deal pricing / margin discussions with Site Leadership.
- Support the Sales team on teleconferences or site visits with the client to confirm the technical aspects of projects are understood and priced appropriately together with gaining an understanding of the actions needed to progress a given deal towards successful closure and assisting / coordinating internally as necessary.
- Coordinating the transition of the project information with technical contacts & project management team for all awarded projects. This includes the timely "file dropping" of quoting information into Change-Point.
- Provide assistance to general enquiries raised by the Sales group.
- Work with Business Development Executives, Site Leadership and Project Managers to promote Patheon and ensure client happiness.
- Must be prepared to present and discuss quotation aspects and analysis to all levels of the organization.
- Participate in continuous improvements within the proposals process.
- Where applicable, performs job responsibilities in compliance with cGMP and all other regulatory agency requirements

**Requirements**:

- Minimum Bachelor level education (B.Sc. or Eng) or equivalent professional experience.
- Very good level of English and Italian language
- spoken and written
- Proficiency with Microsoft Office suite (Outlook, Word, Excel, Power Point)
- Well organized, detail oriented and willing to work in a client facing environment
- Strong communication skills and the ability to work successfully within a diverse group of colleagues in various locations around the globe
- Ability to prioritize multiple tasks, projects and driven towards results
- Ideally hold pharmaceutical services experience, in a pharma development / technical role. Experience in other areas will be evaluated as well (medical devices, cosmetics, chemical).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain **5 reasons to work with us**. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. **#StartYourStory at Thermo Fisher Scientific**, where diverse experiences, backgrounds and perspectives are valued.

Does this sound like something you are interested in?
Applications will be reviewed constantly and the position will be filled once we find the suitable team member.
- Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._
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Regulatory Compliance Officer (Milan)

Milano, Lombardia LGBT Great

Inserito 2 giorni fa

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Overview

PIMCO is a global leader in active fixed income with deep expertise across public and private markets. We invest our clients’ capital across a range of fixed income and credit opportunities, leveraging our decades of experience navigating complex debt markets. Our flexible capital base and deep relationships with issuers have helped us become one of the world’s largest providers of traditional and nontraditional solutions for companies that need financing and investors who seek strong risk-adjusted returns. Since 1971, our people have shaped our organization through a high-performance inclusive culture, in which we celebrate diverse thinking. We invest in our people and strive to imprint our CORE values of Collaboration, Openness, Responsibility and Excellence. We believe each of us is here to help others succeed and this has led to PIMCO being recognized as an innovator, industry thought leader and trusted advisor to our clients.

PIMCO is a global leader in active fixed income. With our launch in 1971 in Newport Beach, California, PIMCO introduced investors to a total return approach to fixed-income investing. In the 50+ years since, we have worked relentlessly to help millions of investors pursue their objectives – regardless of shifting market conditions. As active investors, our goal is not just to find opportunities, but to create them. To this end, we remain firmly committed to the pursuit of our mission: delivering superior investment returns, solutions and service to our clients. Active Management, Tested Process, Culture of Innovation – these elements describe how we operate and innovate to give our clients an edge. We develop solutions based on investors’ needs and investing opportunities – not on near-term asset-raising potential. We invest in top technology, tools and resources to help them succeed.

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Responsibilities
  • Compliance Program Management: Maintain and enhance PIMCO's EMEA Compliance program for Client Facing, Marketing and Portfolio Management activities, ensuring it meets industry standards and regulatory requirements
  • Regulatory Advisory: Provide practical compliance advice on policies and procedures to support business operations, ensuring alignment with applicable regulations
  • Monitoring and Testing: Conduct compliance monitoring and testing to ensure adherence to regulatory frameworks, identifying areas for improvement and implementing necessary changes
  • Regulatory Horizon Scanning: Perform ongoing analysis of the regulatory environment, including "horizon scanning" for changes and expectations from regulators, to enhance the compliance program
  • Collaboration and Project Involvement: Actively contribute to the global regulatory compliance team, focusing on Client Facing, Marketing, Portfolio Management, and Branch and License Oversight, while participating in local, regional, and global projects and working groups
  • Training and Development: Facilitate training sessions and workshops to educate staff on compliance policies, procedures, and best practices
Qualifications
  • Experience: Client-facing, portfolio management and local branch governance experience, with specific compliance expertise in the Italian regulatory framework, particularly within an Asset Manager
  • Experience: Proven experience in managing compliance monitoring programs, with a strong emphasis on risk-based and audit-ready frameworks
  • Regulatory Knowledge: In-depth understanding of Italian and EU regulatory requirements relevant to PIMCO EMEA, with the ability to interpret and apply these regulations effectively
  • Communication Skills: Excellent organizational and communication skills, with the ability to present complex information clearly and concisely to diverse audiences
  • Attention to Detail: Diligent record-keeping and a meticulous, detail-oriented approach to compliance functions, ensuring accuracy and thoroughness in all activities
  • Team Orientation: A collaborative team player with a strong client service orientation, capable of fostering positive working relationships across various departments
  • Adaptability: Flexibility in addressing complex regulatory matters while maintaining a clear understanding of business needs and objectives
  • Professional Standards: Commitment to the highest professional standards and a client service orientation, ensuring that compliance practices support the overall business strategy
Equal Employment Opportunity

PIMCO recruits and hires qualified candidates without regard to race, national origin, ancestry, religion (including religious dress and grooming practices), sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender (including gender identity and expression), age, military or veteran status, disability (physical or mental), any factor prohibited by law, and as such affirms in policy and practice to support and promote the concept of equal employment opportunity and affirmative action, in accordance with all applicable federal, state, provincial and municipal laws. The company also prohibits discrimination on other basis such as medical condition, or marital status under applicable laws. Applicants with Disabilities: PIMCO is an Equal Employment Opportunity / Affirmative Action employer. We provide reasonable accommodation for qualified individuals with disabilities, including veterans, in job application procedures. If you have any difficulty using our online system due to a disability and you would like to request an accommodation, you may contact us at and leave a message. This is a dedicated line designed exclusively to assist job seekers with disabilities to apply online. Only messages left for this purpose will be considered. A response to your request may take up to two business days.

About PIMCO

We believe that active management is the responsible way to invest our clients' assets in fixed income. For 50 years, we have worked relentlessly to help millions of investors pursue their objectives - regardless of shifting market conditions. Our clients rely on an investment process that has been tested in virtually every market environment. Bringing together our investment professionals from across the globe, PIMCO's investment process is designed to promote fresh ideas and differing points of view. We innovate to give our clients an edge. Innovation has long been part of the fabric of PIMCO’s culture. We develop solutions based on investors’ needs and investing opportunities – not on near-term asset-raising potential. We invest in top technology, tools and resources to help them succeed.

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Regulatory Compliance Officer (Milan)

Milano, Lombardia PIMCO Europe Ltd.

Inserito 4 giorni fa

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Descrizione Del Lavoro

Apply locations Milan, ITA time type Full time posted on Posted 3 Days Ago job requisition id R

PIMCO is a global leader in active fixed income with deep expertise across public and private markets. We invest our clients’ capital across a range of fixed income and credit opportunities, leveraging our decades of experience navigating complex debt markets. Our flexible capital base and deep relationships with issuers have helped us become one of the world’s largest providers of traditional and nontraditional solutions for companies that need financing and investors who seek strong risk-adjusted returns.

Since 1971, our people have shaped our organization through a high-performance inclusive culture, in which we celebrate diverse thinking. We invest in our people and strive to imprint our CORE values of Collaboration, Openness, Responsibility and Excellence. We believe each of us is here to help others succeed and this has led to PIMCO being recognized as an innovator, industry thought leader and trusted advisor to our clients.

Position Overview

PIMCO is seeking a highly skilled and motivated Compliance Expert to join its EMEA Regulatory Compliance team, based in PIMCO’s Italian Branch in Milan, Italy. The role will focus on client facing activities, marketing, and oversight on portfolio management. The successful candidate will be responsible for maintaining a best-in-class compliance program, providing pragmatic regulatory advice, and working collaboratively with compliance colleagues across PIMCO's legal entities and branches in key locations, including London, Munich, Milan, Madrid, Paris and Zurich.

Key Responsibilities

  • Compliance Program Management : Maintain and enhance PIMCO's EMEA Compliance program for Client Facing, Marketing and Portfolio Management activities, ensuring it meets industry standards and regulatory requirements.
  • Regulatory Advisory : Provide practical compliance advice on policies and procedures to support business operations, ensuring alignment with applicable regulations.
  • Monitoring and Testing : Conduct compliance monitoring and testing to ensure adherence to regulatory frameworks, identifying areas for improvement and implementing necessary changes.
  • Regulatory Horizon Scanning : Perform ongoing analysis of the regulatory environment, including 'horizon scanning' for changes and expectations from regulators, to enhance the compliance program.
  • Collaboration and Project Involvement : Actively contribute to the global regulatory compliance team, focusing on Client Facing, Marketing, Portfolio Management, and Branch and License Oversight, while participating in local, regional, and global projects and working groups.
  • Training and Development : Facilitate training sessions and workshops to educate staff on compliance policies, procedures, and best practices.

Requirements

  • Experience : Proven experience in managing compliance monitoring programs, with a strong emphasis on risk-based and audit-ready frameworks.
  • Regulatory Knowledge : In-depth understanding of Italian and EU regulatory requirements relevant to PIMCO EMEA, with the ability to interpret and apply these regulations effectively.
  • Communication Skills : Excellent organizational and communication skills, with the ability to present complex information clearly and concisely to diverse audiences.
  • Attention to Detail : Diligent record-keeping and a meticulous, detail-oriented approach to compliance functions, ensuring accuracy and thoroughness in all activities.
  • Team Orientation : A collaborative team player with a strong client service orientation, capable of fostering positive working relationships across various departments.
  • Adaptability : Flexibility in addressing complex regulatory matters while maintaining a clear understanding of business needs and objectives.
  • Professional Standards : Commitment to the highest professional standards and a client service orientation, ensuring that compliance practices support the overall business strategy.

Equal Employment Opportunity and Affirmative Action Statement

PIMCO recruits and hires qualified candidates without regard to race, national origin, ancestry, religion (including religious dress and grooming practices), sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender (including gender identity and expression), age, military or veteran status, disability (physical or mental), any factor prohibited by law, and as such affirms in policy and practice to support and promote the concept of equal employment opportunity and affirmative action, in accordance with all applicable federal, state, provincial and municipal laws. The company also prohibits discrimination on other basis such as medical condition, or marital status under applicable laws.

Applicants with Disabilities

PIMCO is an Equal Employment Opportunity / Affirmative Action employer. We provide reasonable accommodation for qualified individuals with disabilities, including veterans, in job application procedures. If you have any difficulty using our online system due to a disability and you would like to request an accommodation, you may contact us at and leave a message. This is a dedicated line designed exclusively to assist job seekers with disabilities to apply online. Only messages left for this purpose will be considered. A response to your request may take up to two business days.

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Regulatory Compliance Officer (Milan)

Milano, Lombardia LGBT Great

Inserito 4 giorni fa

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

PIMCO is a global leader in active fixed income with deep expertise across public and private markets. We invest our clients’ capital across a range of fixed income and credit opportunities, leveraging our decades of experience navigating complex debt markets. Our flexible capital base and deep relationships with issuers have helped us become one of the world’s largest providers of traditional and nontraditional solutions for companies that need financing and investors who seek strong risk-adjusted returns. Since 1971, our people have shaped our organization through a high-performance inclusive culture, in which we celebrate diverse thinking. We invest in our people and strive to imprint our CORE values of Collaboration, Openness, Responsibility and Excellence. We believe each of us is here to help others succeed and this has led to PIMCO being recognized as an innovator, industry thought leader and trusted advisor to our clients. Position Overview PIMCO is seeking a highly skilled and motivated Compliance Expert to join its EMEA Regulatory Compliance team, based in PIMCO’s Italian Branch in Milan, Italy. The role will focus on client facing activities, marketing, and oversight on portfolio management. The successful candidate will be responsible for maintaining a best-in-class compliance program, providing pragmatic regulatory advice, and working collaboratively with compliance colleagues across PIMCO's legal entities and branches in key locations, including London, Munich, Milan, Madrid, Paris and Zurich. Key Responsibilities Compliance Program Management: Maintain and enhance PIMCO's EMEA Compliance program for Client Facing, Marketing and Portfolio Management activities, ensuring it meets industry standards and regulatory requirements Regulatory Advisory: Provide practical compliance advice on policies and procedures to support business operations, ensuring alignment with applicable regulations Monitoring and Testing: Conduct compliance monitoring and testing to ensure adherence to regulatory frameworks, identifying areas for improvement and implementing necessary changes Regulatory Horizon Scanning: Perform ongoing analysis of the regulatory environment, including "horizon scanning" for changes and expectations from regulators, to enhance the compliance program Collaboration and Project Involvement: Actively contribute to the global regulatory compliance team, focusing on Client Facing, Marketing, Portfolio Management, and Branch and License Oversight, while participating in local, regional, and global projects and working groups Training and Development: Facilitate training sessions and workshops to educate staff on compliance policies, procedures, and best practices Requirements Client-facing, portfolio management and local branch governance experience, with specific compliance expertise in the Italian regulatory framework, particularly within an Asset Manager Experience: Proven experience in managing compliance monitoring programs, with a strong emphasis on risk-based and audit-ready frameworks Regulatory Knowledge: In-depth understanding of Italian and EU regulatory requirements relevant to PIMCO EMEA, with the ability to interpret and apply these regulations effectively Communication Skills: Excellent organizational and communication skills, with the ability to present complex information clearly and concisely to diverse audiences Attention to Detail: Diligent record-keeping and a meticulous, detail-oriented approach to compliance functions, ensuring accuracy and thoroughness in all activities Team Orientation: A collaborative team player with a strong client service orientation, capable of fostering positive working relationships across various departments Adaptability: Flexibility in addressing complex regulatory matters while maintaining a clear understanding of business needs and objectives Professional Standards: Commitment to the highest professional standards and a client service orientation, ensuring that compliance practices support the overall business strategy Equal Employment Opportunity and Affirmative Action Statement PIMCO recruits and hires qualified candidates without regard to race, national origin, ancestry, religion (including religious dress and grooming practices), sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender (including gender identity and expression), age, military or veteran status, disability (physical or mental), any factor prohibited by law, and as such affirms in policy and practice to support and promote the concept of equal employment opportunity and affirmative action, in accordance with all applicable federal, state, provincial and municipal laws. The company also prohibits discrimination on other basis such as medical condition, or marital status under applicable laws. Applicants with Disabilities PIMCO is an Equal Employment Opportunity/Affirmative Action employer. We provide reasonable accommodation for qualified individuals with disabilities, including veterans, in job application procedures. If you have any difficulty using our online system due to a disability and you would like to request an accommodation, you may contact us at and leave a message. This is a dedicated line designed exclusively to assist job seekers with disabilities to apply online. Only messages left for this purpose will be considered. A response to your request may take up to two business days. We believe that active management is the responsible way to invest our clients' assets in fixed income. For 50 years, we have worked relentlessly to help millions of investors pursue their objectives - regardless of shifting market conditions. Our clients rely on an investment process that has been tested in virtually every market environment. Bringing together our investment professionals from across the globe, PIMCO's investment process is designed to promote fresh ideas and differing points of view. We innovate to give our clients an edge. Innovation has long been part of the fabric of PIMCO’s culture. Explore how we assess shifting risks and opportunities to build forward-looking solutions for investors.

PIMCO is a global leader in active fixed income. With our launch in 1971 in Newport Beach, California, PIMCO introduced investors to a total return approach to fixed-income investing.In the 50+ years since, we have worked relentlessly to help millions of investors pursue their objectives – regardless of shifting market conditions. As active investors, our goal is not just tofind opportunities, but to create them. To this end, we remain firmly committed to the pursuit of our mission: delivering superior investment returns, solutions and service to our clients.Active ManagementWe take an active approach to fixed income investing – one in which we express high convictionviews without allowing any single risk to dominate returns. Over our 50 year history, we have found this helps us to deliver positive outcomes for investors and avoid outsized risks that maybe inherent in passive approaches.Tested ProcessWe have a proven ability to help investors navigate shifting investment conditions – including times of market stress. Honed over decades, our process has helped millions of investorsmanage risks and pursue returns over meaningful time periods.Culture of InnovationFinancial markets are changing rapidly and it is crucial for investors to adapt. That is why innovation is part of the fabric of our culture. Importantly, we develop solutions based on investors’ needs and investing opportunities – not on near-term asset-raising potential. And we invest in top technology, tools and resources to help them succeed.

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Senior Regulatory Compliance Engineer

Cinisello Balsamo, Lombardia emeis Italia

Inserito 6 giorni fa

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What you will do As a Senior Regulatory Compliance Engineer at Johnson Controls, you will lead and execute regulatory compliance and agency certification efforts for our products. This role ensures that all products meet relevant safety standards, directives, and regulations throughout the entire product lifecycle—from initial concept and design, through testing and production, to ongoing product support. You will collaborate closely with cross-functional design, engineering, and manufacturing teams as well as external certification bodies. Your expertise in certification processes (UL, CE, UKCA) and regulations will be critical in achieving and maintaining necessary approvals to ensure our products can be confidently marketed and used worldwide. Johnson Controls is a global leader in manufacturing, delivering compliant products to every region worldwide. There will be counterpart roles in the company’s three major global regions. While each role primarily focuses on regional needs and compliance, there will be times when cross-regional standards work is required. How you will do it Regulatory Intelligence Serve as the internal subject matter expert (SME) for regulatory requirements and trends in product safety/integrity and electromagnetic compatibility. Lead product compliance planning, strategy, and execution for new product development projects and sustaining engineering efforts. Drive product lifecycle management around safety compliance during the new product development process (NPI). Develop conformity assessment plans, processes and procedures to ensure harmonized global compliance strategy for JCI Global Products & Solutions. Represent Johnson Controls and influence technical committees on key consensus standards organizations (CENELEC, ETSI, IEC, ISO, in EMEA and ANSI, ASHRAE, CSA, NEMA, NFPA, UL in NA). Compliance Management Own and manage the end-to-end agency certification process, including compliance planning, documentation preparation, coordinating lab testing, and obtaining final approvals. Work with Notified Bodies as required to obtain/maintain EC Type Examination Certificates as dictated by regulatory framework per defined module type conformity assessment protocols. Generate and maintain compliance documentation and support quality audits and continuous improvement initiatives. Regional Compliance Requirements Ensure compliance with regional regulations and related normative consensus standards as outlined below: North America : USA Regulations: CFR Canadian Regulations: Applicable Codes & Standards: UL, equivalent CSA Europe: EU Directives UKCA Applicable Standards (IEC/ETSI): EN International: IEC standards What we look for Bachelor's degree or university degree in Electrical Engineering or a related technical field. Demonstrated experience in driving product safety and regulatory compliance. Preferred experience of 7-10 years of a related industry experience and 5 in product safety and/or risk analysis compliance. Deep understanding of certification requirements and processes, especially for building controls and HVAC applications. Strong working knowledge of IEC/EN EMC standards and testing (e.g., EN 61000 series). Working knowledge of Italian and English – written and verbal. Preferred Qualifications Professional certification related to product safety or compliance (e.g., UL Certified Functional Safety Professional). Experience in building automation systems or HVAC control product development. Familiarity with international certification schemes (CE, UKCA, CB Scheme). Understanding of quality management systems (ISO 9001) and regulatory integration in product development. Basic understanding of software or firmware as it relates to compliance (e.g., software safety classifications, EMC considerations). Our benefits Imagine a career that perpetually stretches your capabilities. From managing many of the world’s most iconic buildings to making products that help save lives, the breadth of our opportunities empowers you to chart your own path. We are a truly global company that embraces diversity, rewards hard work and inspires people to reach for more. In an environment that is constantly evolving, we will set the foundation for you to grow and chart a career path that is as unique as you are. As part of our team you’ll have the opportunity to make an impact that people can feel. The world is waiting for you and so are we. For additional information, please visit or follow us @johnsoncontrols on Twitter. We offer : Flexible working hours Agile working / remote working Meal vouchers of €8 Company welfare package Who we are Johnson Controls is a global diversified technology and multi industrial leader, serving a wide range of customers in more than 150 countries. Our 120,000 employees create intelligent buildings, efficient energy solutions, integrated infrastructure and next generation transportation systems that work seamlessly together to deliver on the promise of smart cities and communities. Our commitment to sustainability dates back to our roots in 1885, with the invention of the first electric room thermostat. We are committed to helping our customers win and creating greater value for all of our stakeholders, through strategic focus on our buildings and energy growth platforms.

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Regulatory Compliance Officer (Milan)

Milano, Lombardia PIMCO

Inserito 20 giorni fa

Lavoro visualizzato

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Descrizione Del Lavoro

Regulatory Advisory : Provide practical compliance advice on policies and procedures to support business operations, ensuring alignment with applicable regulations.

Monitoring and Testing : Conduct compliance monitoring and testing to ensure adherence to regulatory frameworks, identifying areas for improvement and implementing necessary changes.

Regulatory Horizon Scanning : Perform ongoing analysis of the regulatory environment, including "horizon scanning" for changes and expectations from regulators, to enhance the compliance program.

Collaboration and Project Involvement : Actively contribute to the global regulatory compliance team, focusing on Client Facing, Marketing, Portfolio Management, and Branch and License Oversight, while participating in local, regional, and global projects and working groups.

Training and Development : Facilitate training sessions and workshops to educate staff on compliance policies, procedures, and best practices.

Requirements

  • Client-facing, portfolio management, and local governance experience, with specific compliance expertise in the Italian regulatory framework, particularly within an Asset Manager.
  • Proven experience in managing compliance monitoring programs, with a strong emphasis on risk-based and audit-ready frameworks.
  • In-depth understanding of Italian and EU regulatory requirements relevant to PIMCO EMEA, with the ability to interpret and apply these regulations effectively.
  • Attention to Detail : Diligent record-keeping and a meticulous, detail-oriented approach to compliance functions, ensuring accuracy and thoroughness in all activities.
  • Team Orientation : A collaborative team player with a strong client service orientation, capable of fostering positive working relationships across various departments.
  • Adaptability : Flexibility in addressing complex regulatory matters while maintaining a clear understanding of business needs and objectives.
  • Professional Standards : Commitment to the highest professional standards and a client service orientation, ensuring that compliance practices support the overall business strategy.

Equal Employment Opportunity and Affirmative Action Statement

PIMCO recruits and hires qualified candidates without regard to race, national origin, ancestry, religion (including religious dress and grooming practices), sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender (including gender identity and expression), age, military or veteran status, disability (physical or mental), any factor prohibited by law, and as such affirms in policy and practice to support and promote the concept of equal employment opportunity and affirmative action, in accordance with all applicable federal, state, provincial and municipal laws. The company also prohibits discrimination on other basis such as medical condition, or marital status under applicable laws.

Applicants with Disabilities

PIMCO is an Equal Employment Opportunity / Affirmative Action employer. We provide reasonable accommodation for qualified individuals with disabilities, including veterans, in job application procedures. If you have any difficulty using our online system due to a disability and you would like to request an accommodation, you may contact us at and leave a message. This is a dedicated line designed exclusively to assist job seekers with disabilities to apply online. Only messages left for this purpose will be considered. A response to your request may take up to two business days.

Job ID R

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Regulatory Compliance Officer (Milan)

Milano, Lombardia PIMCO Europe Ltd.

Inserito 27 giorni fa

Lavoro visualizzato

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Descrizione Del Lavoro

Regulatory Compliance Officer (Milan)

Regulatory Compliance Officer (Milan)

Apply locations Milan, ITA time type Full time posted on Posted 3 Days Ago job requisition id R

PIMCO is a global leader in active fixed income with deep expertise across public and private markets. We invest our clients’ capital across a range of fixed income and credit opportunities, leveraging our decades of experience navigating complex debt markets. Our flexible capital base and deep relationships with issuers have helped us become one of the world’s largest providers of traditional and nontraditional solutions for companies that need financing and investors who seek strong risk-adjusted returns.

Since 1971, our people have shaped our organization through a high-performance inclusive culture, in which we celebrate diverse thinking. We invest in our people and strive to imprint our CORE values of Collaboration, Openness, Responsibility and Excellence. We believe each of us is here to help others succeed and this has led to PIMCO being recognized as an innovator, industry thought leader and trusted advisor to our clients.

Position Overview

PIMCO is seeking a highly skilled and motivated Compliance Expert to join its EMEA Regulatory Compliance team, based in PIMCO’s Italian Branch in Milan, Italy. The role will focus on client facing activities, marketing, and oversight on portfolio management. The successful candidate will be responsible for maintaining a best-in-class compliance program, providing pragmatic regulatory advice, and working collaboratively with compliance colleagues across PIMCO's legal entities and branches in key locations, including London, Munich, Milan, Madrid, Paris and Zurich.

Key Responsibilities

  1. Compliance Program Management: Maintain and enhance PIMCO's EMEA Compliance program for Client Facing, Marketing and Portfolio Management activities, ensuring it meets industry standards and regulatory requirements.
  2. Regulatory Advisory: Provide practical compliance advice on policies and procedures to support business operations, ensuring alignment with applicable regulations.
  3. Monitoring and Testing: Conduct compliance monitoring and testing to ensure adherence to regulatory frameworks, identifying areas for improvement and implementing necessary changes.
  4. Regulatory Horizon Scanning: Perform ongoing analysis of the regulatory environment, including 'horizon scanning' for changes and expectations from regulators, to enhance the compliance program.
  5. Collaboration and Project Involvement: Actively contribute to the global regulatory compliance team, focusing on Client Facing, Marketing, Portfolio Management, and Branch and License Oversight, while participating in local, regional, and global projects and working groups.
  6. Training and Development: Facilitate training sessions and workshops to educate staff on compliance policies, procedures, and best practices.

Requirements

  1. Experience: Proven experience in managing compliance monitoring programs, with a strong emphasis on risk-based and audit-ready frameworks.
  2. Regulatory Knowledge: In-depth understanding of Italian and EU regulatory requirements relevant to PIMCO EMEA, with the ability to interpret and apply these regulations effectively.
  3. Communication Skills: Excellent organizational and communication skills, with the ability to present complex information clearly and concisely to diverse audiences.
  4. Attention to Detail: Diligent record-keeping and a meticulous, detail-oriented approach to compliance functions, ensuring accuracy and thoroughness in all activities.
  5. Team Orientation: A collaborative team player with a strong client service orientation, capable of fostering positive working relationships across various departments.
  6. Adaptability: Flexibility in addressing complex regulatory matters while maintaining a clear understanding of business needs and objectives.
  7. Professional Standards: Commitment to the highest professional standards and a client service orientation, ensuring that compliance practices support the overall business strategy.

Equal Employment Opportunity and Affirmative Action Statement

PIMCO recruits and hires qualified candidates without regard to race, national origin, ancestry, religion (including religious dress and grooming practices), sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender (including gender identity and expression), age, military or veteran status, disability (physical or mental), any factor prohibited by law, and as such affirms in policy and practice to support and promote the concept of equal employment opportunity and affirmative action, in accordance with all applicable federal, state, provincial and municipal laws. The company also prohibits discrimination on other basis such as medical condition, or marital status under applicable laws.

Applicants with Disabilities

PIMCO is an Equal Employment Opportunity/Affirmative Action employer. We provide reasonable accommodation for qualified individuals with disabilities, including veterans, in job application procedures. If you have any difficulty using our online system due to a disability and you would like to request an accommodation, you may contact us at and leave a message. This is a dedicated line designed exclusively to assist job seekers with disabilities to apply online. Only messages left for this purpose will be considered. A response to your request may take up to two business days.

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Informazioni sulle ultime novità Posizione di regulatory affairs Posti di lavoro;/Posti Vacanti nella Monza !

Regulatory Compliance & Projects Liaison - Mrna

Monza, Lombardia Thermo Fisher Scientific

Ieri

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Descrizione Del Lavoro

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

**Discover Impactful Work**:
You will join a newly-established mRNA GMP manufacturing facility in Monza and will take part to the site overall conformance by advising on licensing strategies applicable to the innovative mRNA suite while partnering with the Qualified Person and realizing regulatory compliance activities per domestic & foreign requirements while interacting with relevant health authorities.

You will be instrumental in supporting the mRNA business entity's growth by being the Regulatory and Compliance point of contact for new projects while liaising with Customer’s technical/regulatory counterparts, promoting our services offering and facilitating regulatory related activities.

**A day in the Life**:
Regulatory Knowledge & Expertise

Advance knowledge on Italian laws and regulatory environment by leaning into specialized industry trade association working groups, digest and disseminate information, assist in impact assessment and implementation.

Stay abreast on ATMPs/mRNA regulatory ecosystem in major jurisdictions (EU, USA, ICH) by monitoring relevant pharmaceutical legislation and guidance and leveraging from internal community of practices.

Regulatory compliance

From a site perspective:
Lead the strategy definition for the establishment license extension to meet Customer needs, frame and submit corresponding facility data packages to regulatory agencies (primarily AIFA)

Provide regulatory assessment and guidance on new product introduction

Responsible for the issuance, maintenance and archiving of all domestic and foreign authorizations (AIFA manufacturing/import license & GMP certificate, FDA e-establishment registration, JP accreditation, etc.)

Supervise the life-cycling of Site/Drug Master Files and ensure relevant submissions

Support regulatory inspections and related preparedness activities

Establish and maintain relevant processes/SOPs and systems/database

Collaborate in change management related to site regulatory compliance duties

From a product perspective:
Responsible for the setting and maintenance of Customer's product registration information (CMC data base)Accountable for the translation of product registration information into production and quality control master documents through key materials review (e.g. drug substance/bulk drug substance specifications, batch records)

Collaborate to components compliance and evolving regulations by partnering with Quality Control (e.g. TSE, elemental impurities, nitrosamines.)

Participate to change control process by defining regulatory requirements (e.g. process, batch size, starting material supplier change.)

Set-up and optimize necessary regulatory systems and SOP in relation to these activities

Ensure adequate archiving of relevant documents

Project Regulatory Liaison

Be the site regulatory liaison face to the Customer, follow-up on project regulatory submission plan (primarily clinical)

Promote CMC regulatory services as part of our integrated offering concept by connecting and mutualizing capacities through Global Regulatory ATX SME

Regulatory reporting

Responsible for ensuring adherence to key deliverables' regional plan fostering into Global Regulatory Affairs reporting

**Keys to Success**:
Education

Bachelor degree in Life Sciences (e.g. Pharmacy, Chemistry, Microbiology.)

Experience

Minimum **7 years** working in a **regulatory role** with **biopharmaceutical** industry (ideally with exposure to ATMPs)

Knowledge, Skills, Abilities

Well-versed on site licensing requirements for clinical and commercial bulk manufacturing according to AIFA, EMA and FDA primarily as well as having an understanding of the respective procedures

General knowledge of phase-appropriate biologics CMC regulatory requirements for clinical and commercial bulk manufacturing in a GMP environment

Adaptable to a dynamic work environment

Agile in interacting with management & leadership as well as Customers and other external partners

Customer-centric attitude with strong business acument

Ability to work with cross-functional teams as well as in a matrixed environment

Ability to prioritize workload to meet timelines

Effective verbal and written communication sk
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Global Regulatory Compliance Excellence Specialist - M / F / X

Milano, Lombardia Mars, Incorporated and its Affiliates

Inserito 4 giorni fa

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Descrizione Del Lavoro

Job Description : Location : Aimargues

Segment : Royal Canin

Contract Type : Permanent

Royal Canin Regulatory Affairs (RA) is investing in empowering its people to make the organization more agile, efficient, and effective in delivering solutions that meet an increasingly complex and evolving regulatory landscape. Our ambition is to continually improve existing activities, deliver them to the highest standard, and prepare for the challenges of tomorrow.

The mission of the Global Regulatory Compliance Excellence Team is to equip Royal Canin associates with the capabilities, data, processes, and tools they need to achieve best-in-class performance in Product and Trade Regulatory compliance — faster and more effectively than the competition, both today and in the future.

To fulfill this mission, the Regulatory Compliance Excellence Specialist will :

Drive initiatives to strengthen the capabilities of the Regulatory Team.

Ensure the quality, relevance, and accessibility of the RA collective knowledge base.

Lead selected activities within our Continuous Improvement program and Regulatory Risk Management framework.

Track, measure, and report on progress, KPIs, and key functional metrics.

What are we looking for?

Master’s degree in Life Sciences, Biomedical / Chemical Engineering, Food Industry Engineering, or Data Science.

2–3+ years of experience in regulated industries (e.g., food, feed, life sciences) in a similar role, or with proven experience in data visualization (working with data engineers / scientists), or in Quality Management Systems (including process management, data quality, and governance).

Fluent in English; additional languages are an asset.

Solid technical expertise with collaborative platforms and data-visualization tools (e.g., Power BI, Smartsheet).

Strong interest in digital solutions and their application to Compliance & Quality. Proven ability to work effectively across cultures, functions, and geographies, maintaining strong communication and collaboration.

Organized and proactive in managing recurring tasks through structured scheduling.

Open-minded, willing to challenge existing processes, and able to drive and support the implementation of new ways of working; experience in highly regulated environments is a plus.

What will be your key responsabilities? Knowledge management

Responsible for the structured use of collaborative platforms to share knowledge and coordinate activities (e.g., MsTeams, MyMarsU groups, Sharepoints), ensuring that those live workspaces are continuously updated with reliable information easily accessible to Regulatory associates.

Responsible for Royal Canin Horizon Scanning Process and for ensuring complementary collaboration with Corporate SRA.

Set up and facilitate maintenance of the global frameworks used to structure the Regulatory function : Org chart, Meeting structure, Roles & key Tasks for core Responsibilities and decision making forums

Capabilities building

Responsible for the Onboarding & Training Programs and the access to training materials

Facilitate the execution of the technical and soft skills training program offered to Regulatory associates

Support the development of all training materials (e.g., e-learnings) related to the deployment of RA processes and WoW focusing on : the selection of agencies to partner with, the compliance of the delivered solution with our Corporate Guidelines, the consistency of our pool of trainings, their shelf-life and the benchmark of best practices in and outside Mars

Continuous improvement

Measure and report KPIs and Metrics for the RA organization, reflecting the efficiency and effectiveness of our RA processes, tools and programs, demonstrating our compliance to Mars Corporate Standards, and giving visibility on RA contribution to the Business.

Support the preparation of RA to the Quality Management Review, coordinate audits preparation and follow-up on agreed related action plans.

Track & report progress on executing agreed risk mitigation measures and CAPAs within the Regulatory Risk Management Program

Drive selected CI projects within the Regulatory Affairs function that relate to the areas of expertise.

Team operations

Responsible for the application of the Indirect Purchasing Governance within RA

Responsible for creating & closing purchase orders and ensuring the compliance of the related Supplier documentation

Support on Budget control & tracking

Coordinate and facilitate the Regulatory Affairs Community calls

Support Team gathering organization

What can you expect from Mars?

At Mars, we believe in a relationship of mutual trust, dignity and respect between our company and Associates that is more meaningful than the standard employer / employee relationship.

As Associates, we can expect to be respected, supported and valued as individuals, to be treated fairly and equitably.

The opportunity to learn and develop, taking charge of your own career across Mars.

You will work in a multicultural environment (more than 40 nationalities) and where your dog will be welcomed by more than 100 other Associates’ dogs at the office!

You will work in a unique campus, which gathers more than 800 Associates working for : the international HQ, the French subsidiary, two laboratories, a kennel and a cattery with more than 200 cats & dogs, and finally the most important factory of the Royal Canin group

J-18808-Ljbffr

#J-18808-Ljbffr
Siamo spiacenti, questo lavoro non è disponibile nella tua regione

Global Regulatory Compliance Excellence Specialist - M/F/X

Milano, Lombardia Mars, Incorporated and its Affiliates

Inserito 27 giorni fa

Lavoro visualizzato

Tocca di nuovo per chiudere

Descrizione Del Lavoro

Job Description:

Location : Aimargues

Segment : Royal Canin

Contract Type : Permanent

Royal Canin Regulatory Affairs (RA) is investing in empowering its people to make the organization more agile, efficient, and effective in delivering solutions that meet an increasingly complex and evolving regulatory landscape. Our ambition is to continually improve existing activities, deliver them to the highest standard, and prepare for the challenges of tomorrow.

The mission of the Global Regulatory Compliance Excellence Team is to equip Royal Canin associates with the capabilities, data, processes, and tools they need to achieve best-in-class performance in Product and Trade Regulatory compliance — faster and more effectively than the competition, both today and in the future.

To fulfill this mission, the Regulatory Compliance Excellence Specialist will:

  • Drive initiatives to strengthen the capabilities of the Regulatory Team.

  • Ensure the quality, relevance, and accessibility of the RA collective knowledge base.

  • Lead selected activities within our Continuous Improvement program and Regulatory Risk Management framework.

  • Track, measure, and report on progress, KPIs, and key functional metrics.

What are we looking for?
  • Master’s degree in Life Sciences, Biomedical/Chemical Engineering, Food Industry Engineering, or Data Science.

  • 2–3+ years of experience in regulated industries (e.g., food, feed, life sciences) in a similar role, or with proven experience in data visualization (working with data engineers/scientists), or in Quality Management Systems (including process management, data quality, and governance).

  • Fluent in English; additional languages are an asset.

  • Solid technical expertise with collaborative platforms and data-visualization tools (e.g., Power BI, Smartsheet).

  • Strong interest in digital solutions and their application to Compliance & Quality. Proven ability to work effectively across cultures, functions, and geographies, maintaining strong communication and collaboration.

  • Organized and proactive in managing recurring tasks through structured scheduling.

  • Open-minded, willing to challenge existing processes, and able to drive and support the implementation of new ways of working; experience in highly regulated environments is a plus.

What will be your key responsabilities? Knowledge management

  • Responsible for the structured use of collaborative platforms to share knowledge and coordinate activities (e.g., MsTeams, MyMarsU groups, Sharepoints), ensuring that those live workspaces are continuously updated with reliable information easily accessible to Regulatory associates.

  • Responsible for Royal Canin Horizon Scanning Process and for ensuring complementary collaboration with Corporate SRA.

  • Set up and facilitate maintenance of the global frameworks used to structure the Regulatory function: Org chart, Meeting structure, Roles & key Tasks for core Responsibilities and decision making forums

Capabilities building
  • Responsible for the Onboarding & Training Programs and the access to training materials

  • Facilitate the execution of the technical and soft skills training program offered to Regulatory associates

  • Support the development of all training materials (e.g., e-learnings) related to the deployment of RA processes and WoW focusing on: the selection of agencies to partner with, the compliance of the delivered solution with our Corporate Guidelines, the consistency of our pool of trainings, their shelf-life and the benchmark of best practices in and outside Mars

Continuous improvement

  • Measure and report KPIs and Metrics for the RA organization, reflecting the efficiency and effectiveness of our RA processes, tools and programs, demonstrating our compliance to Mars Corporate Standards, and giving visibility on RA contribution to the Business.

  • Support the preparation of RA to the Quality Management Review, coordinate audits preparation and follow-up on agreed related action plans.

  • Track & report progress on executing agreed risk mitigation measures and CAPAs within the Regulatory Risk Management Program

  • Drive selected CI projects within the Regulatory Affairs function that relate to the areas of expertise.

Team operations

  • Responsible for the application of the Indirect Purchasing Governance within RA

  • Responsible for creating & closing purchase orders and ensuring the compliance of the related Supplier documentation

  • Support on Budget control & tracking

  • Coordinate and facilitate the Regulatory Affairs Community calls

  • Support Team gathering organization

What can you expect from Mars?
  • At Mars, we believe in a relationship of mutual trust, dignity and respect between our company and Associates that is more meaningful than the standard employer/employee relationship.

  • As Associates, we can expect to be respected, supported and valued as individuals, to be treated fairly and equitably.

  • The opportunity to learn and develop, taking charge of your own career across Mars.

  • You will work in a multicultural environment (more than 40 nationalities) and where your dog will be welcomed by more than 100 other Associates’ dogs at the office!

  • You will work in a unique campus, which gathers more than 800 Associates working for: the international HQ, the French subsidiary, two laboratories, a kennel and a cattery with more than 200 cats & dogs, and finally the most important factory of the Royal Canin group

#J-18808-Ljbffr
Siamo spiacenti, questo lavoro non è disponibile nella tua regione

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