CMC Regulatory Affairs Consultant

High Wycombe
3 days ago
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CK Group are recruiting for a CMC Regulatory Affairs Consultant to join a company in the Pharmaceutical industry at their site based in High Wycombe on a on a contract basis for 6 months.

Salary:

£45-£62.93 per hour PAYE or £65-84.55 per hour Umbrella

CMC Regulatory Affairs Consultant Role:

  • Responsible for the development of CMC/technical regulatory strategies across the EMEA  

  • Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims

  • Manages the global or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant
  • Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain & local business representatives.
  • Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional & business Leadership teams

    Your Background:

    • Relevant Bachelor's Degree or equivalent work experience in pharmaceutical CMC regulatory affairs
    • Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices
    • Knowledge of regulatory frameworks and external environments in the EU/ EMEA , & the ability to apply these to regulatory solutions throughout the product lifecycle.
    • Solid understanding of regulatory CMC in the markets of relevance
    • Strong project management skills.

    Company:

    Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

    Location:

    This role is based at our clients site in High Wycombe. This is a hybrid role with 2-3 days expected on site.

    Apply:

    For more information, or to apply for this CMC Regulatory Affairs Consultant role please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).

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

    Please note:  This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check

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