Senior Director - Regulatory Affairs ATMP/CGT

England Permanent View Job Description
The Senior Director, Regulatory Affairs provides support to the Regulatory Affairs team across a range of projects as needed to support the group's activities, and works with the Vice President, Regulatory Affairs, for oversight of the team.
  • 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

Contact
Chloe Baverstock
Quote job ref
JN-012025-6652118
Phone number
+44 1727 730 144

Job summary

Job function
Life Sciences
Subsector
Regulatory Affairs
Sector
Healthcare / Pharmaceutical
Location
England
Contract type
Permanent
Consultant name
Chloe Baverstock
Consultant phone
+44 1727 730 144
Job reference
JN-012025-6652118