Regulatory Affairs Manager - CMC




Administration, Administrator


£281 to £300 Per Day



Contract Type:


Date Posted:

10/11/2023 12:54:00

My client is a global biopharma company. They are seeking a Regulatory Affairs Manager (CMC) to join our Regulatory Affairs Team based in Cambridge on a 12 month contract.

Hybrid working

Key Responsibilities

  • Co-ordinate the preparation of high quality CMC documents to support regulatory submissions in International regions, (Asia, Latin America, Middle East, Eastern Europe and Africa)
  • Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
  • Co-ordinate the preparation of responses to CMC questions from regulatory authorities
  • Maintain an up-to-date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner

Knowledge, Experience and Skills

  • Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
  • Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
  • Well versed and competent with regulatory documentation and submission management systems
  • Excellent verbal, written and interpersonal communication skills are required
  • Must have excellent organizational skills and an ability to work on a number of projects with tight timelines.

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.