Regulatory Affairs Manager

6 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.

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