Regulatory Affairs Associate Director Global CMC (biologics) - M4 Corridor

Reference: OLI10571UK

Expiry Date: 24-10-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs Associate Director Global CMC (biologics) - M4 Corridor

“Due to further planned expansion my client is seeking an Associate Director Regulatory CMC GRL for a for an exciting brand/portfolio leadership role with matrix reporting based in the South-East, M4 Corridor.”

My client is a global SME biopharmaceutical company with a strong development pipeline and a number of Blockbuster marketed products. Although considered medium in size, their spend on R&D make them competitive at the highest level and sales have continued to rise and rise year on year. With 5 major product launches planned over the next 3-4 years they are hitting impressive levels of growth and achievement.

For Regulatory Affairs CMC, they offer roles at EU and Global levels from their global head office based in the South-East/M4 Corridor and have gained a great reputation for giving regulatory professionals real career progression including direct people management.

The Role:

Your duties will include responsibility for leading global CMC regulatory strategy for biologics in development. This will include HA meetings and negotiations for FDA and EMA. You will also lead and matrix manage for internal & external teams on assigned projects for the preparation and review of IND/IMPDs, NDA/BLAs and EU and International MAA/BLAs.

Experience need:

Ideally you will offer extensive CMC regulatory project management and leadership experience with biologics in development, having working closely with manufacturing sites, R&D and regional regulatory colleagues, with an enthusiastic, positive, and proactive approach, with a determination to succeed. You will have at least 7-10 years in Regulatory Affairs CMC and have experience of European & International CMC regulatory submissions, requirements and procedures.


The package on offer is excellent and includes a full and comprehensive benefits package with full medical coverage for you and your family. The salary, bonus and car allowance are very competitive and you will receive a yearly stock options package. There is great flexibility around home working and time spent in the office, which offers a very nice work-life balance. 


Based in the M4 Corridor, my client is easily commutable from Maidenhead, Slough, High Wycombe, West London and Oxford. Parking is available.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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