Senior Director - Regulatory Affairs ATMP/CGT

TN United Kingdom; Greater London; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Director for Regulatory Affairs specializing in Advanced Therapy Medicinal Products (ATMP) and Cell and Gene Therapies (CGT). This strategic role involves leading regulatory initiatives, managing client projects, and preparing essential submission documents for market access. The ideal candidate will work closely with senior leadership to develop team structures and ensure successful interactions with regulatory agencies. This is an exciting opportunity to make a significant impact in a growing consultancy focused on innovative therapies.

Qualifications

• Proven experience in regulatory affairs within ATMP/CGT.
• Strong strategic planning and project management skills.

Responsibilities

• Lead and strategize in regulatory affairs within ATMP/CGT.
• Manage client projects and provide regulatory advice.
• Prepare regulatory submission documents and lead negotiations.

Skills

Regulatory Affairs

Strategic Planning

Project Management

Client Management

Education

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Job description

Senior Director - Regulatory Affairs ATMP/CGT, England, England

This is a hands-on and strategic senior director position in the field of ATMP / CGT.

Client:

Page Personnel

Location:

England, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

490f269d40c7

Job Views:

3

Posted:

05.05.2025

Expiry Date:

19.06.2025

Job Description:

• Lead and strategize in regulatory affairs within ATMP / CGT
• Work closely with the Vice President, Regulatory Affairs, on team development and structure
• Manage client projects, providing strategic regulatory advice considering guidelines and measures for market access
• Prepare regulatory submission documents such as orphan drug applications, clinical trial applications, and marketing authorizations
• Lead interactions and negotiations with regulatory agencies to meet client goals

About Our Client

Our client is a growing research and development consultancy specializing in innovative therapies.

The Successful Applicant

Senior Director - Regulatory Affairs in ATMP/CGT