Regulatory Affairs Manager - CTA

£55 - £65 per hour
  1. Contract
  2. Project Manager
  3. United Kingdom
London, England
Posting date: 07 Dec 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Regulatory Affairs Manager - CTA to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from the UK.


  • Accountable for CTA proposals for phase III study, which involves evaluation of CRO drafted proposal documents, handling response to queries, and any other study regulatory actions.
  • Handle post-approval proposals for EU, GB, and Switzerland for a marketed product.
  • You will be accountable for handling EU scientific advice actions, which involves proposal of briefing document, meeting preparation, direct contact with health authorities, etc.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level in a scientific field, though an advanced degree would be ideal but not necessary for the role.
  • Demonstrable experience within regulatory affairs method.
  • Familiarity with haematology products would be preferable but other therapeutic areas will be taken into consideration.
  • Acquaintance engaging with regulatory authorities as the main point of contact on proposals and/or health meeting(s).
  • Exhibit a firm commitment to accomplishing corporate gals while upholding the highest ethical, regulatory and scientific standards.
  • A background in practicing sound judgment as it links to risk assessment.
  • Communication skills both verbally and in writing with the ability to be highly conversant.
  • Expertise on new and developing guidelines and regulations.
  • Comprehension of GMPs, GLPs and GCPs, as well as of where to seek and how to understand regulatory information.
  • Works well in a team.
  • Fluency in the English language.

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

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.