Regional Regulatory Leader (m/f/d)
Regional Regulatory Leader
m / f / d)
Freelance / temporary employment for a project Bern Start date : asap Reference number : 768359 / 1
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Your responsibilities
- Serve as a Regional Regulatory Lead for the assigned product portfolio, Therapeutic area Haematology 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 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 , Commercial, Manufacturing, Supply Chain, and Medical Affairs to enhance connectivity
- Stay informed about international legislation and guidelines for biological products and related initiatives , rare diseases, orphan drugs
Your profile
- A degree in Life Sciences, preferably with a post-graduate qualification. Degree in Drug Regulatory Affairs advantageous
- Experience within the international region, supported by additional pharmaceutical or industry experience
- Profound knowledge 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
Your benefits
- A very renowned company
- A highly motivated team and an open way of communication
Regional Regulatory Leader (m/f/d)
Serve as a Regional Regulatory Lead for the assigned product portfolio, Therapeutic area Haematology and countries. Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements. Build strong relationships with regional regulatory agencies, utilizin...
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