Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

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

Requirements:

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.

Responsibilities:

  • 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 emaynard@barringtonjames.com.

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

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
RH6 9AU
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.