Regional Regulatory Leader (m/f/d)

Hays
Berna, Berne
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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
    • Più di 30 giorni fa