CMC Regulatory Affairs Consultant

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 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 132 033.

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.