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Regional Regulatory Scientist – GRA intercontinental Region – 5161 LBD

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

We are looking for a Regional Regulatory Scientist. This is a 6-month contract with possible extension, based in Bern, Switzerland.

Main Responsibilities:

  • Support GRA Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU).  
  • Support life-cycle management to ensure timely regulatory submission within ICO Region.
  • Collect the documentation and request and track its translation if needed.
  • Request and track the labelling update as appropriate.
  • Verify the completeness of the documentation package.
  • Dispatch the documentation. 
  • Interact with Global Labelling.
  • Monitor local regulatory activities to ensure business objectives and timely implementation.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • A degree in Biological or Medical Science or Pharmacy or equivalent.
  • At least 1-year professional experience in Regulatory within “international” markets and / or labeling activities.
  • Fluent in English and any other language as Spanish, French, Arabic, Russian is an advantage.
  • Good communication skills.