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Job Details

Regulatory Affairs Manager - CMC - Geneva Based

Company: Barrington James Europe
Location: Geneva
Reference: em-cmc-raman
Closing Date: 13 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: Competitive

Job Summary:

Regulatory Affairs Manager - CMC - Geneva Based - Rapidly growing pharmaceutical company


A unique opportunity has arisen for a Regulatory Affairs Manager to join a market leading pharmaceutical company. The organisation has recently had a new product approved to market and there early development portfolio is increasing so they are looking to appoint a senior member in the Regulatory team to lead a small team and RA/CMC projects. This position will be reporting into the Director of Regulatory Affairs.


  • Work with CMC documentation which can include but not limited to; CTD sections, IMPD, briefing books etc. Conduct a range of regulatory submissions for small molecules and biological pharmaceutical products.
  • Provide leadership on regulatory interactions on CMC related topics, whilst working closely with Regulatory agencies. You would align the global regulatory strategy with CMC filings/submissions.
  • Manage global and regional submissions such as clinical trial applications, new marketing authorization applications, lifecycle management activities and responses to Health Authority questions.

Experience required:

  • Over 4 year’s regulatory affairs experience in the life science industry where you have worked on either development or commercial pharmaceutical products.
  • Experience working with CMC regulations for biological or small molecule compounds.
  • Have an in-depth understanding of technical writing for Biologic CMC regulatory documents, proven participation to EMA CP application or FDA BLA.

I work on a range of interesting positions in Regulatory Affairs that are available within the pharmaceutical industry. I can provide career advice whether you are looking or not, please reach out to me on 01293 776644 or email me on

Apply for this job: Regulatory Affairs Manager - CMC - Geneva Based

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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