Senior Manager/Director Of Regulatory Affairs

5 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.Lead Regulatory Submissions: Oversee the planning, preparation, and timely submission of regulatory documentation (e.g., e CTD Modules 1–5) for product registrations, variations, renewals, and withdrawals, ensuring accuracy and compliance.Serve as the primary regulatory contact for designated product categories (e.g., Manage the creation and upkeep of core product dossiers, ensuring alignment with current regulatory requirements and submission timelines.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.Degree 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., Solid track record in preparing and submitting e CTD dossiers, including CMC M3 content development.Highly organised with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.


  • Medical Device

    2 settimane fa


    Milano, Italia Resourcing Group A tempo pieno

    Medical Device – Regulatory Affairs Director Responsibilities Line management of 10 Regulatory Line Managers Establish and implement regulatory strategies ensuring new and existing products comply with the latest global requirements Train the team on EMEA / FDA requirements Qualifications Minimum 8 years in regulatory affairs in the medical device industry...

  • Medical Device

    2 settimane fa


    Milano, Italia Resourcing Group A tempo pieno

    Medical Device – Regulatory Affairs Director Responsibilities Line management of 10 Regulatory Line Managers Establish and implement regulatory strategies ensuring new and existing products comply with the latest global requirements Train the team on EMEA / FDA requirements Qualifications Minimum 8 years in regulatory affairs in the medical device industry...


  • Milano, Italia Resourcing Group A tempo pieno

    A leading recruitment agency is seeking a Regulatory Affairs Director in Milan, Italy.The role involves managing a team of Regulatory Line Managers and ensuring compliance with EMEA and FDA regulatory requirements.Candidates should possess over 8 years of experience in regulatory affairs within the medical device industry, with at least 4 years in a...


  • Milano, Italia Resourcing Group A tempo pieno

    A leading recruitment agency is seeking a Regulatory Affairs Director in Milan, Italy. The role involves managing a team of Regulatory Line Managers and ensuring compliance with EMEA and FDA regulatory requirements. Candidates should possess over 8 years of experience in regulatory affairs within the medical device industry, with at least 4 years in a...


  • Milano, Italia Resourcing Group A tempo pieno

    Director role in Milan, Italy, managing regulatory affairs for medical devices, requiring 8+ years of experience.


  • 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...


  • 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...

  • Medical Device

    2 settimane fa


    Milano, Italia Resourcing Group A tempo pieno

    Medical Device – Regulatory Affairs DirectorResponsibilitiesLine management of 10 Regulatory Line ManagersEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirementsTrain the team on EMEA / FDA requirementsQualificationsMinimum 8 years in regulatory affairs in the medical device...

  • Medical Device

    2 settimane fa


    milano, Italia Altro A tempo pieno

    Medical Device – Regulatory Affairs DirectorResponsibilitiesLine management of 10 Regulatory Line ManagersEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirementsTrain the team on EMEA / FDA requirementsQualificationsMinimum 8 years in regulatory affairs in the medical device...


  • 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...