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Regulatory Affairs: CMC, FDA-EMEA Submissions, Switzerland, Geneva



Geneva, Switzerland 

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Job Description:

Regulatory Affairs: CMC, FDA-EMEA Submissions, Switzerland

We are actively looking for a Regulatory Affairs Manager for a client:
- Life science degree.
- +5 years regulatory experience in the pharmaceutical/biotechnology/life science industry
- Experience in writing CMC regulatory documents
- Experience with EMA and FDA application
- Written and spoken English

- Manage CMC documentation (small molecules and biological radiopharmaceutical products)
- Manage global and regional submissions (clinical trial applications, new marketing authorization applications, lifecycle management activities)
- Responses to Health Authority questions
- Participate in design of global regulatory strategies (development of therapeutic and diagnostic products)
- Participate in RA infra-structure (SOPs)
- Represent Global Regulatory CMC to Quality, Research, Manufacturing, Nonclinical and Clinical teams

Your advantages:
- Innovative radiopharmaceutical company: Molecular Nuclear Medicine (MNM) products
- 21 production and R&D facilities across the world; manufacturing both diagnostics and therapeutic MNM products
- Over 600 employees in 12 different countries
- €110 million of sales in 2016 (+20% vs. 2015)
- Listed on the Nasdaq Global Select

The selection of candidates will end soon!
Location: Geneva, Switzerland
Salary range: Depending on profile and experiences

Contact: Arthur SURET-CANALE
Telephone: +33 17 675 3340 / personal extension: 3412
Email: a.suret-canale@nonstop-recruitment.com

Job Requirements:

Life science degree / 5y Regulatory Affairs experience / CMC experience / FDA submission
Company Info
NonStop Recruitment
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site:
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