Regulatory Affairs Officer: CMC & Biologics, Switzerland
- Employer
- NonStop Consulting
- Location
- Geneva
- Salary
- Negotiable
- Closing date
- Mar 6, 2018
View more
- Sector
- Science, Life Sciences, Cell and Molecular Biology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
Regulatory Affairs Officer: CMC & Biologics, 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
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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