Director for Regulatory CMC Biologics, Switzerland
- Full Time
Director for Regulatory CMC Biologics, Western Switzerland, focus on development projects across EMA and US
Top tier 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 company are quite interesting as they are backed by big pharma, yet have a lot of flexibility and a lean set-up allowing them to be focused. It has many of the benefits of a smaller pharma while still having the stability and long term focus. The role it's self will have a lot of autonomy and will allow you to get fully involved in development projects all the way to commercialisation. I'd recommend it to someone strong in biologics CMC for EMA or FDA who is looking for a step up or to work in a more dynamic environment. 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 key health authorities on subjects such as scientific advice
* Mentoring of junior staff and in the future a focus on building up the division
* 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 this role, or to apply, then send your CV to firstname.lastname@example.org or call me, Matt Beedle, Associate partner for Switzerland on +41435 080817. Please feel free to visit my linked-in profile to see my references/recommendations.
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