Beschreibung
*** Regulatory Affairs Manager - Freelance ***As a Recruiter for the Life Sciences field, I wanted share with you my Regulatory Affairs Manager - FREEANCE function for one of my clients in Germany.
Start ASAP, full or part-time & on a 100% remote basis.
Interested? If so, take a glance at the details below and gladly get in touch at your earliest convenience by email for more information.
Main tasks:
- External support with EU and US approval applications with a focus on CMC
- Creation and testing as well as adjustments of IMPD's
- Preparation and approval of clinical trial applications in Germany, the Netherlands and France
- Answers to health questions from the relevant authorities
Expected skills:
- IMPD experience
- ATMP experience (of advantage)
- Solid kknowledge of module 3 of the eCTD
- Degree in pharmacy, biology, chemistry or a similar subject
- 5 years of experience in regulatory affairs, product development and approval management with a focus on biologics
- Organizational and communication skills in English (oral and written)
- Hands-on mentality
Start: ASAP in full OR part-time capacity
Region: Germany (collaboration is 100% REMOTE)
Duration: 6 month contract (with possibility of extension) over freelance
I look forward to your input and a possible mutual collaboration in the near future.
Warm regards and have a wonderful day,
Charlotte Valentiner
Candidate Team Manager - Life Sciences
Progressive Recruitment
Arnulfstr. 31, 80636 München, Deutschland