Regulatory CMC Dossier Manager (remote)

£65 - £75 per hour
  1. Contract
  2. CMC
  3. United Kingdom
London, England
Posting date: 19 Mar 2024

Proclinical is partnering with a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis with the ability to work remotely from anywhere in the UK. The opening position available is for a Regulatory CMC Manager who is solely focusing on dossiers.


  • Interface directly with CMC/Tech team members, Regulatory, external service providers, and internal stakeholders.
  • Influence or persuade others to accept new ideas, approaches, or concepts.
  • Manage several complex projects with potentially accelerated or standard priority.
  • Act as a mentor to one or more individuals- Contribute to dossier strategy and product development plan creation.
  • Lead and supervise dossier authoring activities for early and late-stage projects.
  • Identify business improvement areas and drive implementation of improvements.
  • Develop process and business improvements within own functional organisation.

Key Skills and Requirements:

  • Strong background in Gene therapies, Technical Dossier Writing, and Development.
  • Ability to work independently and resolve cross-functional issues.
  • Excellent team working skills and ability to coach/mentor others.
  • Proven ability to manage complex projects and programs.
  • Educational background: PhD with Post-doc experience or University degree with significant relevant experience.

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.