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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.
Salary:
Competitive.

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.

Company:
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.

Location:
This role is fully remote.

Apply:
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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