Associate Director Regulatory CMC Biologics, Switzerland
Associate Director for Regulatory CMC Biologics, Western Switzerland, focus on development projects across EMA and US
Great opportunity working with one of the leading biologics development teams in Switzerland. Specifically we are looking for someone strong in regulatory CMC biologics development who can take on critical CMC projects from both regulatory and R&D globally. The specific project this person will be working on will be covering new innovative drug products that expected to be key company products. With this in mind there is a lot of funding and support for this person and it's an excellent chance to lead the CMC development all the way to MA approval.
I'd recommend it to someone strong in biologics CMC for EMA or FDA who is looking for a step up both in terms of products responsibility, but also the chance to lead and mentor people. If you are interested 'in principle', then please contact me.
* Global oversight for key CMC activities
* Close collaboration between analytical and regulatory teams
* Input towards key CMC filings
* Working with health authorities on subjects such as scientific advice
* Mentoring of junior staff
* Proven experience in CMC biologics from a strategic and hands on perspective
* Good experience within pre approval CMC
* Experience dealing with EMA or FDA (Ideally both)
* Fluency in English
For a confidential discussion about regulatory affairs, or to apply, then send me your CV or call me, Matt Beedle, Associate Director for Switzerland. Please feel free to check my linked-in account for my references.
For regular job updates and market information please join the Switzerland regulatory affairs linked-in group. https://www.linkedin.com/groups/4550988
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