Scientific Fellow, Regulatory Affairs

Regulatory AffairsLausanne, Vaud, SwitzerlandTemporary

Description

Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For our Regulatory Affairs department based in Lausanne we are looking for a:

Scientific Fellow, Regulatory Affairs(12 months temporary contract)

Are you interested in acquiring the pharmaceutical regulatory basis on development projects? Join our Regulatory Affairs team and actively support them in regulatory watching and submissions to regulatory agencies. In addition, you will have the opportunity to participate as an observer in key meetings with Regulatory Bodies. You will gain Regulatory knowledge basis of drug development through multi regions (Europe, US, Asia).

Requirements

Your main responsibilities

• Support the preparation of the regulatory documents and identify and review scientific literature to write these documents;


• Prepare of Clinical Trial Application and /or Amendment;


• Support the Senior Regulatory Affairs Managers in the Regulatory Watch including weekly screening of web sites for new regulation/guidelines, selection of relevant regulation/guideline, critical review of relevant regulations/guidelines with DPI department’s representatives.


• Maintain Regulatory Watch up to date; organizing related meetings and preparing meeting minutes.

Your profile

• University education in Science or applied sciences of relevance for the pharmaceutical industry.


• Solid scientific background especially in regard to review and analysis of published literature.


• Previous regulatory knowledge, for example a degree in Regulatory Affairs, is an asset but not a requirement.


• Excellent English knowledge (spoken and written), ideally associated with good writing skills.


• Self-driven and pro-active.


• Able to work in a team.

Debiopharm

Become part of our team, gain hands-on experience and insight into the pharmaceutical industry by joining our traineeship program.

We will give you the opportunity to « put your foot in the stirrup » and offer you:

• An international and highly dynamic environment.


• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry;


• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.