Regulatory Affairs Manager Lisboa

Regulatory Affairs Manager
Lisboa
Lisboa, Lisboa, Portugal

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 regulatory operations across a diverse portfolio of
-
- counter (OTC) and consumer health products. You’ll be working at the heart of a
- paced,
- driven environment, driving dossier strategy, managing global submissions, and collaborating closely with
- functional teams across markets.

Responsibilities:

• Lead Regulatory Submissions:
  
  Oversee the planning, preparation, and timely submission of regulatory documentation (e. G. , e
  CTD 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
  - 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
  - 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 e
  CTD dossiers, including CMC M3 content development.
• Highly organised with excellent attention to detail and ability to manage multiple regulatory projects simultaneously.