Regulatory Affairs Manager

14 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 an exciting opportunity to lead end-to-end regulatory operations across a diverse portfolio of over-the-counter (OTC) and consumer health products. You’ll be working at the heart of a fast-paced, innovation-driven environment, driving dossier strategy, managing global submissions, and collaborating closely with cross-functional teams across markets.ResponsibilitiesLead Regulatory Submissions: Oversee the planning, preparation, and timely submission of regulatory documentation (e.g., eCTD Modules 1–5) for product registrations, variations, renewals, and withdrawals, ensuring accuracy and compliance.Coordinate Stakeholder Engagement: Serve as the primary regulatory contact for designated product categories (e.g., analgesics), fostering effective communication with internal teams and external partners.Maintain Dossier Integrity: Manage the creation and upkeep of core product dossiers, ensuring alignment with current regulatory requirements and submission timelines.Ensure Documentation Readiness: Supervise the organisation and electronic archiving of regulatory records to support accessibility and inspection readiness.Collaborate Across Functions: Work cross-functionally with Regulatory Strategy, R&D, Pharmacovigilance, Quality, and Marketing to ensure regulatory alignment throughout the product lifecycle.RequirementsDegree in Pharmacy, Life Sciences, or a closely related field (Bachelor’s or Master’s level).At least 5 years of hands-on experience in regulatory affairs within the pharmaceutical or healthcare sector.Strong command of international regulatory guidelines (e.g., EMA, ICH, and national health authorities).Solid track record in preparing and submitting eCTD dossiers, including CMC M3 content development.Highly organised with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionStrategy/Planning and Writing/EditingIndustriesPharmaceutical Manufacturing, Consumer Services, and Biotechnology ResearchGet notified about new Regulatory Affairs Manager jobs in Monza, Lombardy, Italy.#J-18808-Ljbffr

  • Regulatory Affairs Manager

    54 minuti 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

    20 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 Manager

    17 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 Scienta Partnering with CDMOs to strengthen their Commercial Teams We'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...

  • Regulatory Affairs Manager

    17 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 ora 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 leadingglobal consumer health businessto find an experiencedGlobal Regulatory Operations Medicine Managerto join their dynamic Regulatory Affairs team.This is an...

  • Global Regulatory Affairs Manager – Non-Pharma

    1 settimana fa

    Milano, Italia Alfasigma A tempo pieno

    A global healthcare company is seeking a Non-Pharma Global Regulatory Affairs Manager based in Milan.The role involves managing regulatory documentation, executing global regulatory strategies, and ensuring compliance for non-pharma products.Candidates should have proven experience in Regulatory Affairs, a background in life sciences, and strong...

  • Regulatory Affairs Manager...

    3 giorni fa

    Milano, Italia Scienta A tempo pieno

    We'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 an exciting opportunity to lead end-to-end regulatory operations across a diverse portfolio of over-the-counter (OTC) and consumer health products.You'll be...

  • Regulatory Affairs Manager

    1 settimana fa

    Milano, Italia Whatjobs A tempo pieno

    Mission:Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...

  • Regulatory Affairs Manager

    2 giorni fa

    Milano, Italia Whatjobs A tempo pieno

    MissionDevelop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.Regulatory affairs Manager is responsible for ensuring that every product their company sells meets relevant...