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Regional/Local Regulatory Head – 5373 LBD
Our client, a large pharmaceutical organization, is looking for a Regional/Local Regulatory Head for a 12-month contract (with possibility of extension) in Bern.
- 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
- 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.