Regulatory Affairs Manager

Scienta; Monza; 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. 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 detail, and a degree in a relevant field. This full-time position offers the chance to work in a fast-paced, innovation-driven environment.

Competenze

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a closely related field.
• At least 5 years of hands‑on experience in regulatory affairs.
• Strong command of international regulatory guidelines.

Mansioni

• Oversee the planning and preparation of regulatory submissions.
• Serve as the primary regulatory contact for designated product categories.
• Manage the creation and upkeep of core product dossiers.

Conoscenze

Regulatory submissions

Documentation readiness

Stakeholder engagement

Regulatory compliance

Project management

Formazione

Degree in Pharmacy or Life Sciences

Descrizione del lavoro

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 organization 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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