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Job Details

Regulatory CMC Manager

Company: Hobson Prior
Location: Cambridgeshire
Reference: RegCMCMan
Closing Date: 27 Dec 18
Type: Contract
Salary (£): On Application
Benefits: Excellent package

Job Summary:

Hobson Prior has an exciting new Regulatory CMC (Chemistry, Manufacturing and Control) Manager job on offer with an exciting research-based biopharmaceutical company based in Cambridge. You will be joining a rapidly developing client who researches, develops and commercialises drugs.

Requirements:

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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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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