Description
Regulatory Affairs Manager - Basel - 8 month 50% contractOur client, an international generics pharmaceutical company is currently looking for a Regulatory Affairs Manager with experience in the Swiss market. You will be acting as the point of contact to authorities and Swissmedic.
Requirements
- Pharmacist or scientist with at least 2 years of experience in Regulatory Affairs.
- Experience in submission of NCEs in the Swiss market and in e CTD Publishing
- You have a very good knowledge of the Swiss environment
- Excellent communicator, both verbal and written.
- Very good knowledge of German and English. Ideally French
Duties and Responsibilities will include
- Preparation and submission of applications for authorization of new submissions, notifications of changes and extensions of approvals from Swissmedic
- Support submission of new products
- Strategy development for products to be submitted
- Point of contact to authorities and control approval pending cases (Swissmedic)
- Maintenance of internal databases
I am a specialized recruiter, currently taking care of various projects within the Regulatory Affairs area in Switzerland. For more information about this role or jobs within related specialist areas please send me your CV as a Word document with your hourly rate expectations for immediate consideration.
You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: Regulatory Affairs Manager, temporary, Swissmedic, Switzerland, freelance, English, German, French, Basel, NCE, eCTD, submissions