Senior Director - Regulatory Affairs ATMP/CGT
Posted 5 days 2 hours ago by Michael Page (UK)
Permanent
Not Specified
Other
England, United Kingdom
Job Description
- Hands on and strategic senior director position
- ATMP / CGT
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