Aktuelle Jobs im Zusammenhang mit Regional/local Regulatory Lead - Bern - CTC Resourcing Solutions


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Regional/local Regulatory Lead

vor 5 Monaten


Bern, Schweiz CTC Resourcing Solutions Vollzeit

**The Life Science Career Network**

**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**.

**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.