Regulatory Affairs Manager

Human Value; Monza; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading global consumer health business seeks an experienced Global Regulatory Operations Medicine Manager to oversee regulatory operations for OTC and consumer health products in Monza, Italy. This role involves managing global submissions, maintaining core product dossiers, and collaborating with cross-functional teams. Candidates should hold a degree in Pharmacy or Life Sciences with at least 5 years of relevant experience. Excellent regulatory knowledge and organizational skills are required.

Competenze

• At least 5 years of experience in regulatory affairs within the pharmaceutical or healthcare sector.
• Solid track record in preparing and submitting eCTD dossiers, including CMC M3 content development.

Mansioni

• Oversee the planning and submission of regulatory documentation for product registrations.
• Serve as the primary regulatory contact for designated product categories.
• Manage the creation and upkeep of core product dossiers.
• Supervise the organisation and electronic archiving of regulatory records.
• Work cross-functionally with various departments to ensure regulatory alignment.

Conoscenze

Strong command of international regulatory guidelines (e.g., EMA, ICH)

Excellent attention to detail

Ability to manage multiple regulatory projects

Formazione

Degree in Pharmacy, Life Sciences, or closely related field

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.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.