Regulatory Affairs Manager

1 settimana fa

Via Milano, Italia Bayer A tempo pieno

Join to apply for the Regulatory Affairs Manager (m/f/d) role at Bayer At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where “Health for all, Hunger for none” is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. The Pharmaceutical Division of Bayer S.p.A. is looking for a motivated and experienced Regulatory Affairs Manager. He/she will contribute to the EU regulatory strategies aligned with national business objectives, ensuring compliance and supporting new product launches and lifecycle management across Pharma and Radiology. The role includes anticipating legislative changes, driving regulatory intelligence and improvement initiatives, and contributing to EU Regulatory Affairs with cross‑functional input and representation in scientific associations. ResponsibilitiesContribution to EU regulatory strategy for development and lifecycle management Critical evaluation and interpretation of complex technical data across assigned therapeutic areas — including preclinical, clinical, pharmacovigilance, and CMC — to ensure alignment with regulatory requirements, business objectives, and global strategies Preparation of the local regulatory environment for launch, including trend analysis, competitor intelligence, and scenario planning Support to EU Regulatory Affairs for fast approvals and optimal labeling tailored to local access needs and leading Health Authority interactions as needed Regulatory lead within launch teams, managing all activities related to product launch and support Price & Reimbursement (P&R) Development of regulatory strategies to support reimbursement negotiations and inform on legislative impacts, risks, and opportunities within cross‑functional teams Ensuring compliance of commercial operations with national legislation and advising on regulatory implications for business Proactively identifying regulatory risks due to evolving local laws and being part of issue managementQualificationsMaster’s Degree in a scientific discipline or related fields Postgraduate master’s in Regulatory Affairs will be considered a plus At least 5 years of previous experience in Regulatory Affairs within the pharmaceutical industry Strong regulatory knowledge of both Italian and EU legislation, with good understanding of Market Access dynamics and commercial needs Experience in Regulatory Affairs activities for medical devices will be considered a plus Flexible, agile, and digitally minded, with a positive attitude toward change and a strong willingness to learn and innovate Residence or domicile in Lombardia is preferred Fluent knowledge of English and Italian mother tongueLocation: Milan Type of contract: Permanent Application Period: – Reference Code: Division: Pharmaceuticals Functional Area: Regulatory Affairs Position Grade: VS 1.1 – A3 Employment Type: Regular Work Time: Full Time Contact:Viale Certosa 130, 20156 #J-18808-Ljbffr

  • Regulatory Affairs Manager

    19 ore fa

    Via Milano, Italia Subbyx A tempo pieno

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from ScientaPartnering with CDMOs to strengthen their Commercial TeamsWe're currently partnering with a leading global consumer health business to find an experienced Global Regulatory Operations Medicine Manager to join their dynamic Regulatory Affairs team.This is...

  • Regulatory Affairs Manager

    1 settimana fa

    Via Milano, Italia Bayer CropScience Limited A tempo pieno

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where "Health for all, Hunger for none" is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Regulatory Affairs Manager

    1 settimana fa

    Via Milano, Italia Bayer CropScience Limited A tempo pieno

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where "Health for all, Hunger for none" is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Regulatory Affairs Manager

    1 settimana fa

    Via Milano, Italia Bayer A tempo pieno

    Join to apply for the Regulatory Affairs Manager (m/f/d) role at BayerAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where “Health for all, Hunger for none” is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique...

  • Regulatory Affairs Manager

    1 settimana fa

    Via Milano, Italia Bayer (Schweiz) AG A tempo pieno

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where Health for all, Hunger for none is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities...

  • Regulatory Affairs Manager

    16 ore fa

    milano, Italia Subbyx A tempo pieno

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from ScientaPartnering with CDMOs to strengthen their Commercial TeamsWe're currently partnering with a leading global consumer health business to find an experienced Global Regulatory Operations Medicine Manager to join their dynamic Regulatory Affairs team.This is...

  • Regulatory Affairs Manager

    3 ore fa

    Milano, Italia Subbyx A tempo pieno

    Get AI-powered advice on this job and more exclusive features.Direct message the job poster from ScientaPartnering with CDMOs to strengthen their Commercial TeamsWe're currently partnering with a leading global consumer health business to find an experienced Global Regulatory Operations Medicine Manager to join their dynamic Regulatory Affairs team.This is...

  • Regulatory Affairs Manager

    7 giorni fa

    milano, Italia Cpl Life Sciences A tempo pieno

    Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Milan, Italy - HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is...

  • Regulatory Affairs Manager

    21 ore fa

    Milano, Italia Cpl Life Sciences A tempo pieno

    Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title:European Regulatory Affairs ManagerLocation:Milan, Italy - HybridRemuneration:Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines.The business is...

  • Regulatory Affairs Project Manager

    4 giorni fa

    Via Milano, Italia ADAMA Ltd. A tempo pieno

    1 day ago Be among the first 25 applicantsJoin ADAMA – A Global Leader in Crop Protection shaping the future of agricultureWith nearly 10,000 employees and $5 billion in annual sales across more than 100 countries, ADAMA is one of the world’s top crop protection companies and part of the Syngenta Group. Our mission is to create simplicity in agriculture...