Regional Regulatory Lead Haematology

vor 1 Woche


Bern, Schweiz Kelly Services (Schweiz) AG Vollzeit

For a worldwide leading biotherapeutics company in Bern we are looking for aRegional Regulatory Lead Haematology (f/m/d) Temporary employment, 100%

Tasks and 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 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, Medical Affairs) to enhance connectivity
  • Stay informed about international legislation and guidelines for biological products and related initiatives (e.g. rare diseases, orphan drugs)

Your profile

  • 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

General information

  • Start date: asap
  • Duration of employment: 12 months
  • Place of work: Bern
  • Workload: 100 % (at least 20% attendance at office in Bern)

If you are interested in this position, please apply online or send your CV to:nicole.blum[at]gigroup.com



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