Regulatory Affairs Specialist

3 giorni fa


Milano, Lombardia, Italia Pfizer A tempo pieno

Job Summary

  • Represent the EU region for regulatory sciences in early-stage oncology portfolio management, collaborating with stakeholders to ensure timely submissions and approvals.
  • Contribute regional strategic expertise to the Global Regulatory Strategic Team (GRST) and lead EU regulatory strategies for assigned projects/products.
  • Ensure optimal regulatory interactions with Health Authorities, focusing on the designated early-stage oncology portfolio within the EU.

Key Responsibilities

  • Accountable for EU contributions to Global Regulatory Strategies and implementation plans, including core labels, risk registers, and submission activities.
  • Develop and implement regulatory strategies, ensuring compliance with EU regulations and guidelines, and managing risks associated with emerging technical data.
  • Collaborate with project teams to provide required regulatory contributions (CTA, etc.) and promote business compliance with Regulatory standards.
  • Develop and maintain constructive working relationships with Health Authority contacts in the EU region and engage in activities to influence the EU regulatory environment.

Organizational Relationships

  • Reports to the Early Phase Oncology EU Lead and works closely with GRS colleagues, project teams, and external contacts in Regulatory Agencies within the EU region.
  • Ensures alignment with GRL and the Early Phase Oncology Global Head, promoting a collaborative and cohesive approach to regulatory affairs.

Qualifications and Skills

  • Scientific degree (higher degree preferred but not essential); proven experience in managing national and EU regulatory processes and registration aspects of the drug development process.
  • Strong communication, negotiation, and presentation skills, with the ability to communicate complex information effectively to various audiences, including senior management.


  • Milano, Lombardia, Italia PharmaLex A tempo pieno

    About the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at PharmaLex. As a Regulatory Affairs Specialist, you will be responsible for managing the preparation and revision of informative texts for healthcare professionals and patients, as well as ensuring compliance with regulatory requirements.Your...


  • Milano, Lombardia, Italia Pfizer, S.A. De C.V A tempo pieno

    {"title": "Regulatory Affairs Specialist", "content": "Job SummaryPfizer is seeking a highly skilled Regulatory Affairs Specialist to join our team in the EU region. As a key member of our Global Regulatory Strategic Team, you will be responsible for providing regional strategic expertise and leading EU regulatory strategies for assigned projects and...


  • Milano, Lombardia, Italia Hover Senior Living Community A tempo pieno

    Job SummaryThe Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and corporate policies.The Regulatory Affairs Senior Specialist supports interactions with the national Regulatory Authorities, i.e....


  • Milano, Lombardia, Italia CooperCompanies A tempo pieno

    Job Title: Senior Regulatory Affairs SpecialistCooperVision is a leading manufacturer of soft contact lenses with a presence in over 100 countries. We're committed to creating an inclusive and engaging workplace where everyone's contribution counts.About the Role:We're seeking a Senior Regulatory Affairs Specialist to provide regulatory support, guidance,...


  • Milano, Lombardia, Italia Recordati A tempo pieno

    Job DescriptionRecordati is seeking a highly skilled Regulatory Affairs Specialist to join its international team. As a key member of the Corporate Regulatory Affairs department, you will be responsible for the management of regulatory activities for medicinal products for human use.Key Responsibilities:Preparation, review, and submission of relevant...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist for Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our team in ensuring compliance with regulatory requirements for our medical devices.Prepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files,...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist for Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to play a key role in ensuring compliance with regulatory requirements for our medical devices.This individual will collaborate cross-functionally with internal teams to support product development, registration, and...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team.Key Responsibilities:Prepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files, Design Dossiers, and other regulatory filings...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Job SummaryWe are seeking a highly motivated Regulatory Affairs Specialist to support our medical devices team.Main ResponsibilitiesAs a Regulatory Affairs Specialist, you will play a key role in ensuring compliance with regulatory requirements for our medical devices. Key responsibilities include preparing and submitting regulatory submissions to regulatory...


  • Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pieno

    Job Title: Regulatory Affairs ManagerW EXECUTIVE S.R.L. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring that our products meet all relevant regulatory requirements and standards.Key Responsibilities:Develop and execute regulatory strategies and plans to ensure...


  • Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pieno

    Job Title: Regulatory Affairs ManagerCompany: W EXECUTIVE S.R.L.Location: MilanoAs a Regulatory Affairs Manager at W EXECUTIVE S.R.L., you will be responsible for ensuring that our company's products comply with all relevant laws and regulations. This includes developing and executing regulatory strategies, managing product registrations, and providing...


  • Milano, Lombardia, Italia The Kraft Heinz Company A tempo pieno

    Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at The Kraft Heinz Company. As a key member of our Legal, Government and Regulatory department, you will be responsible for ensuring all product labels comply with food legislation and company policies.Key Responsibilities:Ensure...


  • Milano, Lombardia, Italia The Kraft Heinz Company A tempo pieno

    Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at The Kraft Heinz Company. As a key member of our Legal, Government and Regulatory department, you will be responsible for ensuring all product labels comply with food legislation and company policies.Key Responsibilities:Ensure...


  • Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pieno

    Regulatory Affairs ManagerW EXECUTIVE S.R.L. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring that our products meet all relevant regulatory requirements and standards.Key Responsibilities:Develop and execute regulatory strategies and plans to ensure compliance...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Page Personnel. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Page Personnel. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...


  • Milano, Lombardia, Italia CooperCompanies A tempo pieno

    About the RoleWe are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at CooperCompanies. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesRegulatory Support and Guidance: Provide...


  • Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs - Medical Device Lifecycle Management to join their team. This role offers a unique...