Regional Regulatory Lead

Vor 3 Tagen

Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

For our client we are looking for a

Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant) (m/f/d) 100%

Tasks & 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, 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).

Must Haves:

  • 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.

General Information:

  • Start date:07.2024
  • End date: 1 year
  • Work location: Bern
  • Remote/Home Office: Attendance at office at least 20%
  • Workload: 100%

Your Application:

Please apply online. For further information about the position, please contact your Kelly recruiter, Fatbardha Igrishta (Fatbardha.igrishta[a]kellyservices.ch).

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