Regulatory Affairs Manager CMC

Regulatory Affairs Manager CMC

  • Location

    South East England, United Kingdom

  • Sector:

    Regulatory Affairs

  • Job type:


  • Salary:

    £42,000 - £55,000

  • Contact:

    Callum Sparkes

  • Job ref:


  • Published:

    almost 2 years ago

  • Expiry date:


  • Consultant:


Senior Regulatory Affairs Manager - CMC


Permanent – South East UK


The Role


To manage the writing/drafting, compilation and review of dossier sections (IMPD, IND, NDA or MAA) based from source technical or quality reports, to support company clinical trials applications or applications for Commercial Licences. The role also involves activities for agency meeting briefing books (CMC) and responses to agency quality questions.



Key Responsibilities


  • To well represent the CMC RA team in CBD, CBDV programs
  • To project manage draft CMC sections/dossiers and organise effective functional review for the CMC sections of Marketing Authorisation Applications (MAAs) and New Drug Applications (NDAs) and for IMPDs/INDs
  • To revise documents in line with peer comments/critique
  • To ensure QC to finalised CMC documents and acceptability to the group, before use in publication
  • To have strong awareness of GMP compliance and data integrity
  • To manage work in order to meet agreed submission schedules


Essential Skills


  • Degree level education in Life Sciences, and a further degree preferred
  • Over 4 years’ experience of working in CMC Regulatory Affairs/ or Regulatory Affairs in the Pharmaceutical industry
  • Practical experience of CMC dossier sections
  • Experience of CMC regulatory submissions, receipt of questions and making robust responses for competent authorities
  • Strong knowledge of ICH quality regulatory requirements
  • An understanding of the inter-relationships between Quality, Safety and Efficacy aspects of MAAs, INDs and IMPDs
  • Communication skills including written and presentational
  • IT competency
  • Regulatory CMC document writing skills, in being concise and writing with very high clarity
  • Proven organisational skills, particularly when time constrained


Location: South East