Regulatory Affairs Specialist (Carregado, Portugal)
Role
We are looking for a Regulatory Affairs Specialist to join our team. The professional will be responsible for ensuring the regulatory compliance of products and processes, guaranteeing that all activities meet the applicable legal, technical, and scientific requirements.
Responsibilities
- Prepare, submit and follow up on regulatory submissions to national and international authorities
- Prepare and review technical and scientific documentation required for product registrations, renewals and variations
- Support the authorization and commercialization process of new products, ensuring compliance with legal timelines
- Review and approve labelling texts, packaging, leaflets and promotional materials in line with applicable legislation
- Contribute to product safety monitoring on the market, participating in pharmacovigilance activities
- Maintain up-to-date regulatory files and manage the corresponding archive
- Provide technical regulatory support to other departments (Quality, R&D, Production, Marketing, etc.)
- Develop internal regulatory strategies and procedures in compliance with current legislation
- Ensure effective communication with regulatory authorities, partners, and internal departments on regulatory matters
Requirements
- Degree or Integrated Master’s in Pharmaceutical Sciences, or degree in health and chemistry-related sciences (Biology, Biochemistry, Chemistry)
- Strong focus on quality, compliance and meeting deadlines
- Problem-solving orientation and ability to work effectively in a team
- Driver's license (preferred)
- Available immediately (preferred)
- Languages: English (Advanced), Portuguese (Advanced)