Senior Manager Regulatory Affairs CMC, for NCE’s - UK

Reference: Oli10486C1

Expiry Date: 04-05-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Greater London
United Kingdom

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Job Description

Senior Manager Regulatory Affairs CMC, for NCE’s - South East, UK

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

We are recruiting for a Senior Manager Regulatory Affairs CMC to work on small molecule products in development for an established and successful Pharmaceutical company based in the South East, M4 Corridor.

Our client is a leading, research driven Pharmaceutical Company with some exciting new products coming in Ph 2 and Ph 3 as well as a busy early development pipeline. This company has already grown to become a major R&D organization and are committed to increasing access to high-quality healthcare products around the world. This company is now expanding their Regulatory CMC team globally and is seeking to hire a Regulatory Affairs CMC Snr Manager – Clinical Lead.

The location is easily commutable by train from London, Reading, High Wycombe, and Windsor and is easily accessible by car with company car parking available.

Nature and scope of this opportunity:

  • You will be working on a variety of projects. Based on your strengths and experience you would either be supporting a new MAA for a product in PIII or working on working on CTAs for products in development (IMPDs, INDs, etc.).
  • You will have both strategic and operational input for a variety of projects, potentially from early phase through to MAA as part of the Global Regulatory Affairs CMC development team. You will work with an experienced GRL who will help you develop and get to the next level in an organization where individuals are judged on their own merits.

Who’s right for the job?

  • It is essential to have at least 5 years of Regulatory Affairs CMC experience supporting and authoring M3 section for small molecules or biologics.
  • Experience in direct communication with the Health Authorities on CMC matters.
  • You would be a good communicator who is also eager to learn and develop.
  • You would have leadership and project management skills.
  • Fluent English is a must as this is the business language.


This is a permanent opportunity and the salary is very competitive and includes a good bonus and an extensive company benefits package. There is also good flexibility to work 2 – 3 days a week from home. This role offers great projects to work on a real career development plan designed to give you all the experience you need to make the jump up to Regulatory Affairs Associate Director CMC.

Who are we?

ADV Talent is a niche recruitment agency hiring for major bio/pharmaceutical companies and healthcare organizations mainly in the field of Regulatory Affairs and Regulatory CMC. We want individuals to be self-actualized for their own hiring process. This brings out the individuals to embrace change and identify with their next career move as an opportunity to grow. By this, our applicants grow, and so do our clients.

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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