Regulatory CMC Manager

Location
Cambridgeshire
Salary
On Application
Posted
27 Nov 2018
Closes
27 Dec 2018
Ref
RegCMCMan
Contract Type
Contract

Regulatory CMC Manager – Cambridge

Job Responsibilities

  • Prepare CMC documents, to a high standard, to support regulatory submissions internationally (Asia, Latin America, Middle East, Eastern Europe and Africa)
  • Deliver the CMC components for marketing applications, variations and renewals, working with pharmaceutical development, manufacturing, QA and external partners
  • Pre-emptively find responses to potential CMC questions from regulatory authorities
  • Remain aware of CMC regulatory requirements for applicable territories and communicate key intelligence to the organisation

Key Skills

  • Excellent organisational skills and the skill to work on numerous projects simultaneously, in high-pressure environments
  • Strong verbal, written and interpersonal communication skills
  • Competent in regulatory documentation and submission management systems

Requirements

  • Significant experience in regulatory affairs
  • Extensive knowledge of regulatory requirements, including ICH and regional requirements
  • Able to prepare and finalise CMC regulatory dossiers and maintain existing product licenses on an ongoing basis

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading specialist life science recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

 

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