Senior Director - Regulatory Affairs ATMP/CGT
Michael Page England
About Our Client
My client is a growing research and development consultancy.
Job Description
Senior Director - Regulatory Affairs ATMP/CGT- Works with and deputises for the Vice President, Regulatory Affairs, on short- and long-term team development, growth and structure
- Lead client projects, providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives and early market access
- Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, clinical trial applications and investigational new drug applications, PIPs/PSPs, PRIME/BTD/RMAT and marketing authorisation applications
- Lead regulatory agency interactions/negotiations to ensure client goals are met
The Successful Applicant
Senior Director - Regulatory Affairs ATMP/CGT
What's on Offer
Competitive Basic and Package
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