Senior Director – Regulatory Affairs ATMP/CGT

Job title:

Senior Director – Regulatory Affairs ATMP/CGT

Company

Michael Page

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.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 metHands on and strategic senior director position ATMP / CGTSenior Director – Regulatory Affairs ATMP/CGTMy client is a growing research and development consultancy.Competitive Basic and Package

Expected salary

£100000 per year

Location

England

Job date

Sat, 15 Feb 2025 01:04:06 GMT

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