Regulatory Affairs Manager

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

Descrizione del lavoro

A leading global consumer health business is seeking an experienced Global Regulatory Operations Medicine Manager in Rome. You will lead regulatory operations for over-the-counter and consumer health products, overseeing submissions and maintaining regulatory compliance. A degree in Pharmacy or Life Sciences and a minimum of 5 years' experience in regulatory affairs is essential. This role offers a dynamic environment and significant responsibilities within the Regulatory Affairs team.

Competenze

• At least 5 years of hands-on experience in regulatory affairs.
• Strong command of international regulatory guidelines.
• 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 product categories.
• Manage the creation and upkeep of core product dossiers.
• Supervise the organization of regulatory records.
• Work cross-functionally to ensure regulatory alignment.

Conoscenze

Regulatory Submissions

Stakeholder Engagement

Dossier Management

Cross-functional Collaboration

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.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 organized with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.