Regulatory Affairs Manager

Scienta; Monza; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading global consumer health business in Italy is seeking an experienced Global Regulatory Operations Medicine Manager to join their dynamic team. You will lead regulatory submissions, manage core product dossiers, and collaborate with various functions in a fast-paced environment. The ideal candidate will have a degree in Pharmacy or Life Sciences and at least 5 years of experience in regulatory affairs. Strong organizational skills and attention to detail are essential.

Competenze

• Bachelor’s or Master’s level degree in Pharmacy, Life Sciences, or related field.
• Minimum 5 years of experience in regulatory affairs in pharmaceuticals or healthcare.
• Familiarity with international regulatory guidelines (EMA, ICH).
• Experience in preparing and submitting eCTD dossiers.
• Ability to manage multiple projects effectively.

Mansioni

• Oversee the submission of regulatory documentation for product registrations.
• Act as the primary regulatory contact for product categories.
• Manage core product dossiers to ensure compliance.
• Organize and archive regulatory records for inspections.
• Collaborate with various teams for regulatory alignment.

Conoscenze

Regulatory affairs expertise

Cross-functional collaboration

Project management

Attention to detail

Formazione

Degree in Pharmacy or Life Sciences

Descrizione del lavoro

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., 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.