Regional/Local Regulatory Lead - 5373

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View: 136

Update day: 26-03-2024

Location: Bern Bern BE

Category: Other

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Contract

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The Life Science Career NetworkCTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.Regional/Local Regulatory Head - 5373 LBDOur client, a large pharmaceutical organization, is looking for a Regional/Local Regulatory Head for a 12-month contract (with possibility of extension) in Bern .Responsibilities
  • Support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region
  • Primarily managing distributors regulatory activities for South East Europe but also experience in Latin-America, Middle east, Africa, CIS, Russia, Turkey an advantage
  • Monitor local regulatory activities to ensure business objectives and timely implementation
  • Responsible for a specific submission package (new product/indication submission, variations, renewal) from preparation to submission in the region, by coordinating the preparation of the modules with the appropriate stakeholders
  • Interact with Global Labelling relating to the labeling activities in the Region
  • Support for the overall coordination and dispatch of responses to Health Authority questions, which include: preparing answers for simple questions not requiring product expertise or input from other internal stakeholders.
  • Supporting internal stakeholders for the strategy, planning and preparation of response for complex scientific questions requiring product expertise
Qualifications
  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Degree in Biological or Medical Science or Pharmacy or equivalent
  • At least 3 years professional experience in Regulatory Affairs within international markets
  • Good communication skills
  • Experience with Veeva or RIM system
  • Fluent in English and any other language as Spanish, Arabic, Russian, Serbo-Croat is an advantage.
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Deadline: 10-05-2024

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