For our client, one of the leading Healthcare & Life Sciences companies based in Bern, Swisslinx is seeking a highly motivated individual to take on a challenging role as a CMC Regulatory Affairs specialist.
Duration: 1 year with the possibility of extension.
- Responsible for providing expertise on Regulatory Affairs matters and manage CMC submissions
- Revise technical documentation and annual report for FDA/US
- Manage operational activities for the Variation of submissions
- Change assessments in TrackWise for multisite biologics products
- A minimum of 3 years of experience in Regulatory Affairs, CMC submissions
- Knowledge about Module 32A1 and TrackWise is highly preferred
- Excellent organization and time management skills
- Fluency in English, German is preferred
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to firstname.lastname@example.org.
We look forward to hearing from you!