Senior Director - Regulatory Affairs ATMP/CGT

• 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

1. Works with and deputises for the Vice President, Regulatory Affairs, on short- and long-term team development, growth and structure.
2. 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.
3. 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.
4. 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