Global Regulatory Operations Lead...
3 giorni fa
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.
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Global Regulatory Operations Lead
2 giorni fa
Monza, Italia Scienta A tempo pienoWe'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...
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Global Regulatory Operations Lead: Dossier Strategy
4 settimane fa
Monza, Italia Bebeecompliance A tempo pienoA leading health compliance firm based in Monza is seeking an experienced professional to lead global regulatory operations across a diverse portfolio of products. The ideal candidate will possess strong leadership skills and the ability to drive dossier strategy. This role offers a unique chance to thrive in a dynamic environment focused on innovation and...
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Global Regulatory Submissions Lead, OTC
6 giorni fa
Monza, Italia Scienta A tempo pienoA leading global consumer health business is seeking an experienced Global Regulatory Operations Medicine Manager in Monza, Lombardy. In this mid-senior level role, you'll lead regulatory submissions and ensure compliance across a diverse range of over-the-counter products. Ideal candidates will have 5+ years in regulatory affairs, strong attention to...
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Global Regulatory Submissions Lead, OTC
6 giorni fa
Monza, Italia Scienta A tempo pienoA leading global consumer health business is seeking an experienced Global Regulatory Operations Medicine Manager in Monza, Lombardy. In this mid-senior level role, you'll lead regulatory submissions and ensure compliance across a diverse range of over-the-counter products. Ideal candidates will have 5+ years in regulatory affairs, strong attention to...
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Regulatory Operations Specialist
4 settimane fa
Monza, Italia Bebeecompliance A tempo pienoJob Description We are seeking an experienced professional to lead end-to-end regulatory operations across a diverse portfolio of over-the-counter (OTC) and consumer health products. This is an exciting opportunity to work at the heart of a fast‑paced, innovation‑driven environment where you will be responsible for ensuring compliance with relevant...
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Monza, Italia MENARINI Group A tempo pienoGlobal Regulatory Affairs Operations Innovation and Information Management Senior Associate Join to apply for the Global Regulatory Affairs Operations Innovation and Information Management Senior Associate role at MENARINI Group . Overview Join our Global Regulatory Affairs Operations department as a Senior Associate in the Innovation and Information...
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Regulatory Affairs Manager
2 settimane fa
Monza, Italia Scienta A tempo pienoWe'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...
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Regulatory Affairs Manager
2 settimane fa
Monza, Italia Scienta A tempo pienoWe'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...
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Regulatory Affairs Manager
2 settimane fa
Monza, Italia Scienta A tempo pienoWe'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...
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Regulatory Affairs Manager
2 settimane fa
Monza, Italia Scienta A tempo pienoWe'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...
