Regional Regulatory Lead Immunology

vor 3 Wochen


Bern, Bern, Schweiz Gi Life Sciences Basel Vollzeit
Job Summary

We are seeking a highly skilled Regional Regulatory Lead Immunology to join our team at Gi Life Sciences Basel. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and aligning regulatory activities with regional and global strategies.

Key Responsibilities
  • Lead regional regulatory activities for the Immunology portfolio, ensuring compliance with local regulations and guidelines.
  • Collaborate with internal functions to enhance connectivity and improve submission and approval timelines.
  • Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes.
  • Stay informed about international legislation and guidelines for biological products and related initiatives.
Requirements
  • 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.
What We Offer
  • 100% workload with a minimum of 20% attendance at our office in Bern.
  • Opportunity to work with a dynamic team and contribute to the success of our company.


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