CMC Manager

  • Salary: 65,000
  • REF Number: 00034673
  • Consultant: Oliver Care
  • Contact: 01438 842 976
  • Date Published: 06.01.2016
  • Closed Date: 12.05.2016
  • Sector:
  • Location: South Wales,
  • Discipline:

Oliver Care at CK Clinical is recruiting for a CMC Manager to join a company focusing on stem cell research at their site based in South Wales on a permanent basis.

The main purpose of the role will be to

  • Be the CMC expert for the company, responsible for the CMC regulatory strategy and submissions on a global basis
  • Work with the CMC and QA teams for all CMC aspects of the company
  • Prepare, compile and submit CMC sections for CTAs/INDs/MAAs to regulatory authorities

Further responsibilities will include:

  • Ensuring the regulatory affairs department comply with GMP/GCP requirements
  • Acting as deputy to the Head of Regulatory in their absence
  • Keeping up to date on all relevant CMC regulatory requirements

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or relevant experience
  • Significant senior regulatory CMC experience
  • Biologics experience is essential and knowledge of cell therapy is also desirable

This is an excellent opportunity to join a forward thinking company working in an exciting innovative industry.

For more information or to apply for this position, please contact Oliver Care on 01438 842 976 or email ocare@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34673 in all correspondence.

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