Regional Regulatory Lead
Vor 2 Tagen
Regional Regulatory Lead (m/f/d)
Freelance/temporary employment for a project in Bern
Start date: asap
Reference number: 768358/1
Your responsibilities
- 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 such as Commercial, Manufacturing, Supply Chain, and Medical Affairs to enhance connectivity.
- Stay informed about international legislation and guidelines for biological products and related initiatives, including rare diseases and orphan drugs.
Your profile
- A degree in Life Sciences, preferably with a post-graduate qualification. Degree in Drug Regulatory Affairs is 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.
Your benefits
- A very renowned company.
- A highly motivated team and an open way of communication.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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