Regulatory Affairs CMC Consultant

£55 - £65 per hour
  1. Contract
  2. CMC
  3. United Kingdom
Surrey, England
Posting date: 06 Sep 2023

Proclinical are recruiting for a Regulatory Affairs CMC Consultant to join an organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.


  • Conduct regulatory research to obtain pertinent histories, precedence and any other information pertinent to regional product advancement.
  • Write and arrange replies to queries across allocated products and countries.
  • Guarantee CMC regional concerns affect international regulatory method for suggested CMC filings are considered and risks recognised with suitable contingency methods.
  • Evaluate the preparation of M2 and 3 CMC factors of filings and examine fitness of purpose for proposal within the pertinent countries.
  • Offer direction for regulatory examinations of change control requests.
  • You will share regulatory information and implications with shareholders on an ongoing basis and offer advice on regional considerations.
  • Other duties may be assigned.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.