Regulatory Affairs Manager

4 giorni fa


Monza, 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 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.Responsibilities:- Lead 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.Requirements:- 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., 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.



  • Monza, 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...


  • Monza, 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...


  • Monza, 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...


  • Monza, Lombardia, Italia Scienta A tempo pieno

    We'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 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...


  • Monza, Italia Scienta A tempo pieno

    We'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 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...

  • Ehs Regulatory

    1 giorno fa


    monza, Italia Trace One A tempo pieno

    OverviewDescrizione dell’offerta di lavoroContext: Within the Regulatory & Scientific Affairs team and in an international and multicultural environment, as Junior Specialist of EHS Regulatory & Scientific Affairs you will ensure full regulatory compliance of products by monitoring requirements, updating technical databases, and executing assigned...

  • Ehs Regulatory

    1 giorno fa


    Monza, Italia Trace One A tempo pieno

    OverviewDescrizione dell’offerta di lavoroContext: Within the Regulatory & Scientific Affairs team and in an international and multicultural environment, as Junior Specialist of EHS Regulatory & Scientific Affairs you will ensure full regulatory compliance of products by monitoring requirements, updating technical databases, and executing assigned...

  • Ehs Regulatory

    2 giorni fa


    Monza, Italia Trace One A tempo pieno

    Overview Descrizione dell’offerta di lavoro Context: Within the Regulatory & Scientific Affairs team and in an international and multicultural environment, as Junior Specialist of EHS Regulatory & Scientific Affairs you will ensure full regulatory compliance of products by monitoring requirements, updating technical databases, and executing assigned...


  • Monza, Italia Jobbit A tempo pieno

    A pharmaceutical client in Florence is looking for a Regulatory Affairs Coordinator for Central and Latin America.The successful candidate will ensure compliance and support timely submissions across diverse markets.With at least 5 years of experience in Regulatory Affairs and a master's degree in a scientific field, you will work collaboratively with...


  • Monza, Italia Jobbit A tempo pieno

    A pharmaceutical client in Florence is looking for a Regulatory Affairs Coordinator for Central and Latin America. The successful candidate will ensure compliance and support timely submissions across diverse markets. With at least 5 years of experience in Regulatory Affairs and a master's degree in a scientific field, you will work collaboratively with...