Regulatory Affairs Manager

Subbyx; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global consumer health business is seeking an experienced Global Regulatory Operations Medicine Manager in Monza, Lombardy. This role involves overseeing regulatory submissions and managing product dossiers. Candidates should have a degree in Pharmacy or a related field, with at least 5 years of regulatory affairs experience, preferably in the pharmaceutical or healthcare sector. The position offers an exciting opportunity to work in a fast-paced, innovative environment.

Competenze

• At least 5 years of hands-on experience in regulatory affairs within the pharmaceutical sector.
• Strong command of international regulatory guidelines (e.g., EMA, ICH).
• Solid track record in preparing and submitting eCTD dossiers.

Mansioni

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

Conoscenze

Regulatory submissions

Stakeholder engagement

Dossier management

Documentation readiness

Cross-functional collaboration

Formazione

Degree in Pharmacy or Life Sciences

Descrizione del lavoro

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Direct message the job poster from Scienta

Partnering with CDMOs to strengthen their Commercial Teams

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Strategy/Planning and Writing/Editing

Industries

• Pharmaceutical Manufacturing, Consumer Services, and Biotechnology Research

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