Regional Regulatory Lead Immunology, Respiratory, Transplant Specialist

vor 3 Wochen


Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit

Key Responsibilities

  • As a Regional Regulatory Lead for Immunology, Respiratory, and Transplant products, you will be responsible for aligning all regulatory activities with regional and global strategies, ensuring compliance with local requirements.
  • You will communicate effectively to ensure that dossiers meet regional and local content and format requirements.
  • Additionally, you will coordinate, compile, and track high-quality documentation for submissions, including new license applications and lifecycle activities.
  • Strong relationships with regional regulatory agencies will be built, utilizing negotiation and influencing skills for positive outcomes.
  • Collaboration with internal functions, such as Commercial, Manufacturing, Supply Chain, and Medical Affairs, will enhance connectivity.
  • Staying informed about international legislation and guidelines for biological products and related initiatives will be essential.

Requirements

  • A degree in Life Sciences is required.
  • 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.


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