CMC Regulatory Affairs Consultant

High Wycombe
2 weeks 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 contract basis for 6 months.

Salary:

£45.00 - £62.93 per hour PAYE or £65.00 - £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:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only).

Please note: 

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

If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news

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