Head of Regulatory CMC

Job Category:
Pharmaceuticals / Biotechnology / Forensics / Medical Devices
Job Type:
North East
North East England
Salary Description:
Negotiable + Benefits
SCI Recruitment for Scientists
Job Ref:

Head of Regulatory CMC

Ref: 19638


Our client is a major Contract Research and Development Organisation (CRDO), providing the pharmaceutical industry with a comprehensive range of services.

They are focused on Process Research, Development, Scale-Up and small scale manufacturing, including bioanalysis, DMPK, regulatory and consulting services, covering drug candidates in Development and launched to the Market.


The role will include:

  • The provision of managerial and regulatory leadership for a team of scientists engaged in the preparation of global CMC regulatory submissions
  • Actively coordinating, producing and reviewing CMC regulatory documentation
  • Participating in discussions with potential CMC regulatory clients and assisting in the preparation of work proposals in this area
  • Providing API and drug product related CMC regulatory advice to colleagues and company clients
  • Providing regulatory advice and documentation to clients planning to attend meetings with regulatory agencies and supporting responses to regulatory questions
  • Working flexibly to meet business needs
  • Excellent written and oral communication skills together with good interpersonal and organisational skills are essential


The successful applicant will have an in-depth knowledge of small molecule CMC regulatory requirements across the clinical phases and sufficient knowledge of large molecule regulatory submissions to allow their preparation within the team.


Role: Permanent

Based: North East England

Salary: Negotiable + Benefits


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Contact Details:
SCI Recruitment for Scientists
Tel: 01606 818290
Contact: Andy Cuthbert

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