CMC Regulatory Affairs Specialist

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11916en
  1. Contract
  2. English
  3. Associate
  4. Research & Development
  5. Bern
  6. Healthcare & Life Sciences

Skills

Regulatory Affairs, Coordination, CMC, Submissions

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This vacancy has now expired
About our client
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. (complete remote work possible)

Your Mission:
- 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
- Evaluate CMC technical and scientific information for compliance with regulatory

Your Profile:
- A minimum of 3 years of experience in Regulatory Affairs, CMC submissions
- Strong background in natural sciences with focus on biological medicinal products
- 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 fiona.maqi@swisslinx.com.

We look forward to hearing from you!

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