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CMC Regulatory Consultant

Hampshire   •  Contract/Temporary, Full time

CK Group are recruiting for a CMC Regulatory Consultant to join a company in the animal health and pharmaceutical industry working remotely on a contract basis for 6 months.

CMC Regulatory Consultant Role:

  • Global analytical development and strategic CMC direction of assigned APIs during their development phase.
  • Supervision of CMC work packages at cooperation partners regarding the development of analytical methods, chemical characterization, control strategies, and specifications for Active Pharmaceutical Ingredients (APIs), impurities, starting materials and intermediates; performance evaluation of external partners.
  • Preparation of registration relevant documents for worldwide market authorization (including answers to authority requests) ensuring compliance with all relevant external regulations related to CMC-submissions (e.g. VICH, FDA, EMA, EPA).

Your Background:

  • Master degree and PhD in a scientific discipline (e.g. Chemistry, Pharmacy) with strong background in analytics (both quantification and spectroscopy); normally followed by postdoctoral fellowship at an internationally recognized institution.
  • Specialist knowledge of analytical development with a curiosity and willingness to develop in new areas.
  • Preferably several years? experience of managing a laboratory in an industrial company.
  • Professional experience in veterinary/pharmaceutical/agricultural research, development, manufacturing, control and assessment of APIs and products.
  • Experience of submission of CMC-related /analytical topics along with GLP, GMP and other quality systems.

Our client specialises in animal health. They advance their vision of food and companionship enriching life by developing innovative solutions that protect and enhance animal health.

This role is fully remote.

For more information or to apply for this CMC Regulatory Consultant position, please contact Lucy on 01246 457725 or email pharmacontracts@ckagroup.co.uk, quoting job ref 51539.

It is essential that applicants hold entitlement to work in the UK.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Lucy Stendall
  • Phone: 01246 457733
  • Reference: 51539
  • Posted: 27th August 2021
  • Expires: 24th September 2021

CK Group

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