Regulatory Affairs Specialist: CMC, Biologics, FDA, Switzerland

Location
Geneva
Salary
Negotiable
Posted
Feb 01, 2018
Closes
Mar 01, 2018
Ref
ASC170217.2
Contact
Arthur Suret-Canale
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

Regulatory Affairs Specialist: CMC, Biologics, FDA, 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 Biologic CMC regulatory documents
- Experience with EMA and FDA application
- Written and spoken English

Missions:
- 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

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