Senior Manager for Regulatory CMC
Senior Manager for Regulatory CMC Biologics, Western Switzerland, focus on BLA/MAA submissions both across approval and LCM
I'm currently searching for an experienced CMC biologics expert to join a small but growing team in a very well funded start-up. The company have a very broad portfolio and with many products coming through, it really is the time for regulatory to shine. With such high demand both currently and in the future, we are looking for someone with strong technical ability and passion, who is up for the fast paced and exciting world of start-up life. The hiring manager is someone I've known for a long time and has a great reputation within industry. On top of this the company have very high level support and funding backed with a highly professional team.
If you could be interested 'in principle', then please feel free to contact me.
Help to bring a BLA/MAA through the questions and approval and further progression into life cycle management
* Close collaboration between analytical and regulatory teams
* Input towards key CMC filings
* Working with health authorities on subjects such as scientific advice
- Proven experience in regulatory CMC biologics (specifically mAbs) from a strategic and hands on perspective
- Experience in BLA/MAA preparation and set up
- Experience dealing with EMA or FDA (Ideally both)
- Fluency in English
For a confidential discussion about this role, then send your CV to me, Matt Beedle, Executive partner for Switzerland or call me on +41 43 50 80 81. You can find my references on my linked-in profile in case you are curious of my background.
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