Regional Regulatory Lead (m/f/d)
- Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries
- Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements
- Communicate effectively to ensure that dossiers meet regional and local content and format requirements
- Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions
- Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes
- Collaborate with internal functions e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs to enhance connectivity
- Stay informed about international legislation and guidelines for biological products and related initiatives e.g., rare diseases, orphan drugs
- A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
- Regulatory experience within the international region, supported by additional pharmaceutical /industry experience
- Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP
- Proficiency in standard regulatory tools : Veeva, DocNet, Trackwise
- A very renowned company
- A highly motivated team and an open way of communication
À propos de l'entreprise