Regional Regulatory Lead (m/w/d)
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Bern, Schweiz |
Temporary Employment
Job title: Regional Regulatory Lead
Industry: Pharma & MedizintechnikSkills: Regulatory Lead,Immunology,Respiratory
Start of project: 14.10.2024
Duration of the project : 12 months
Location: Bern, Schweiz
Tasks:
- 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).
Qualifications & Experience:
- A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At least 3 years of 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
- Attendance in the office at least 20%
Referenznummer: 15182
Branche: Pharma & Medizintechnik
Beginn des Projekts: 14.10.2024
Dauer: 12 months
Anstellungsart: Temporary Employment
Kontakt
Luca Furler