Regional Regulatory Lead Immunology, Respiratory, Transplant (f/m/d)
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- Veröffentlicht:09 Oktober 2024
- Pensum:100%
- Vertrag:Temporär
- Sprache:Englisch (Fliessend)
- Arbeitsort:Bern
For a worldwide leading biotherapeutics company in Bern we are looking for a
Tasks and 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 (e.g. Commercial, Manufacturing, Supply Chain, Medical Affairs) to enhance connectivity
- Stay informed about international legislation and guidelines for biological products and related initiatives (e.g. rare diseases, orphan drugs)
Your profile
- Degree in Life Sciences
- At least 3 years of regulatory experience within the international region, supported by additional pharmaceutical/industry experience
- Understanding of 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
General information
- Start date: asap
- Duration of employment: 12 months
- Place of work: Bern
- Workload: 100% (at least 20% attendance at office in Bern)