Regulatory Affairs Associate Director - 12 month contract
- Employer
- Barrington James
- Location
- Germany (DE)
- Salary
- Competitive rate
- Start date
- 1 Oct 2019
- Closing date
- 31 Oct 2019
View more
- Discipline
- Regulatory Affairs, CMC
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Director/Executive
Job Details
I am currently working with an innovative start up Biotechnology Company based in Germany, near Hamburg, that are seeking an experienced Regulatory Affairs Associate Director to work with them on a 12-month contract.
Responsibilities include:
- Provide support and report to the Regulatory Affairs Director including assisting with the regulatory strategy
- Provide strategic and technical regulatory CMC expertise for new BLA/IND/IMPD/MAA applications, to support robust Module 3 Quality Sections
- Advise on country regulatory requirements in connection with the preparation of regulatory submissions
- Ensure compliance of GMP documentation with regulatory modules
- Perform reviews for CMC submissions (MAA/BLA)
- Point of contact with Regulatory Authorities
Suitable candidates will have:
- At least 7 years’ experience in Regulatory Affairs CMC
- Experience in Biosimilars/Biologics
- Life Science Degree (MSc or PhD)
I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding one of my current vacancies, or simply be made aware of opportunities as they arise then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.
Alternatively e-mail me on JASmith@barringtonjames.com.
I look forward to hearing from you soon!
Jasmine Smith
Contract Consultant ~ Regulatory Affairs
+ 44 (0)1293 77 66 44
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
United Kingdom
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