Expiry Date: 04-02-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs CMC Manager, Switzerland
We are hiring for a Regulatory Affairs CMC Manager to join a successful biopharmaceutical company in Switzerland.
Our client is an expanding, international biopharmaceutical company with an impressive R&D, transforming patient’s lives through pioneering advanced therapies. This is a global company that has grown rapidly and has marketed several dozen very successful drugs.
They are now expanding their Regulatory Affairs CMC team in Switzerland and are looking to hire a versatile Regulatory CMC professional to support marketed products (both small and large molecules) in the EU and subsequently the ROW. You will be supporting and also leading regulatory CMC submissions for assigned projects. This will include writing and reviewing regional CMC submission documents and be responsible for Health Authority interactions. You will provide regional Regulatory CMC expertise and have an input into the Regulatory CMC strategy.
In return, you will have experience supporting and writing MAA/BLAs as part of a bigger team, filing Variations, new indications, tech transfer etc. IMPD experience will be a plus.
This is a permanent role based in Switzerland (German speaking part of the country), close to an international airport. The role comes with a competitive salary package, bonus and company benefits.
To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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