Regulatory Affairs Manager

ILLVA SARONNO HOLDING S.p.A.; Saronno; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading global consumer health company is seeking an experienced Global Regulatory Operations Medicine Manager in Saronno, Lombardy. This role involves leading regulatory operations for OTC and consumer health products, ensuring compliance and collaboration across multiple functions. The ideal candidate should have a degree in Pharmacy or Life Sciences and 5+ years of experience in regulatory affairs. This position offers the chance to shape regulatory strategy in a dynamic environment.

Competenze

• 5+ years of hands-on experience in regulatory affairs.
• Strong command of international regulatory guidelines (EMA, ICH).
• Solid track record in preparing and submitting eCTD dossiers.

Mansioni

• Oversee the submission of regulatory documentation.
• Serve as primary regulatory contact for product categories.
• Manage the creation and upkeep of core product dossiers.
• Supervise regulatory records organization and archiving.
• Work cross-functionally to ensure regulatory alignment.

Conoscenze

International regulatory guidelines knowledge

Project management

Attention to detail

Formazione

Degree in Pharmacy or Life Sciences

Descrizione del lavoro

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

Location: Monza, Lombardy, Italy.