Regional Regulatory Leader

Vor 4 Tagen

Bern, Schweiz Hays Vollzeit

**My duties**
- You will support Global RA Intercontinental team members to obtain and maintain registration of products in collaboration with the local regulatory teams and countries within the Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU))
- Also you monitor local regulatory activities to ensure business objectives and timely implementation
- You are 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 2-5 with stakeholders and preparing Module 1
- To interact with Global Labelling relating to the labeling activities in the Region is another task
- Also you support the overall coordination and dispatch of responses to Health Authority questions
- Preparing answers for simple questions not requiring product expertise or input from other internal stakeholders is part of this role as well
- Supporting internal stakeholders for the strategy, planning and preparation of response for complex scientific questions requiring product expertise is also your responibility

**My qualifications**
- You have a degree in Biological or Medical Science or Pharmacy or equivalent and some years professional experience in Regulatory Affairs in International Countries
- You have Regulatory submission experience within “international” markets
- Also you bring good communication skills
- You are able to talk fluent English

**My benefits**
- You will work in a very international and well known bio-pharmaceutical comnpany
- There is the chance to stay within the company in a long term contract

**About Hays**

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

**My contact at Hays**

**My contact person**Edgar Lingert

**Reference number**606324/1

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