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Regulatory Affairs Manager CMC

Regulatory Affairs Manager CMC

  • Location

    South East England, United Kingdom

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    £42,000 - £55,000

  • Contact:

    Callum Sparkes

  • Job ref:

    40372

  • Published:

    over 1 year ago

  • Expiry date:

    2019-05-19

  • 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