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Regulatory CMC Director / Associate Director - Biologics




Hertfordshire, England

Job Type

Full Time

Reference No: RI2020001005

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Job Description

Location: A mixture of office working (Hertfordshire) & home working

Salary: Competitive Salary on offer + Bonus and Pension

The Regulatory Affairs CMC Expert will provide development stage CMC advice for a broad range of product types including New Chemical Entities, Biologics, Cell and Gene Therapy programmes. The role will require the following activities;

  • Write IMPDs / INDs and quality related documentation for clinical development programmes.
  • Advise CMC related strategies to ensure compliant clinical programmes leading into and throughout clinical studies.
  • Implement robust CMC compliance programmes covering all aspects from monitoring changes to manufacturing processes, specifications and shelf life maintenance.
  • Is a point of contact for agency interactions and negotiates pragmatic solutions during grounds for nonacceptance and throughout the duration of clinical studies.
  • Leads CMC related discussions during scientific advice with National Agencies, the EMA, and FDA (including end of Phase 2 meetings).
  • IMPD / IND and Module 3 dossier writing
Applicant Requirements
  • Degree or higher in Chemistry, Biochemistry, or related scientific disciplines
  • Experience in leading CMC programmes at a technical level
  • Prior experience in agency interactions and leading discussions with regulatory assessors
  • Demonstrable experience in writing CMC/Module 3 dossier content, IMPDs and INDs for biologics products
Reference No: RI2020001005

Hiring Manager(s)


Head of Regulatory Affairs Recruitment at Linkfield Life Sciences

Email Natalie

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