CK Group are recruiting for a CMC Regulatory Affairs Consultant
Join a company in the Pharmaceutical industry at their site in High Wycombe on a 6-month contract basis.
Salary: £45.00 - £62.93 per hour PAYE or £65.00 - £84.55 per hour Umbrella.
Role: CMC Regulatory Affairs Consultant
* Responsible for developing CMC/technical regulatory strategies across the EMEA.
* Leads a Regulatory Affairs team to ensure successful registration of new products, line extensions, and new indications and claims.
* Manages global or regional regulatory deliverables for drugs, dietary supplements, and medical devices as relevant.
* Builds strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain, and local business representatives.
* Represents the Regulatory Affairs CMC function in various franchise, functional, and leadership teams.
Your Background
* Bachelor’s Degree or equivalent experience in pharmaceutical CMC regulatory affairs.
* Experience with regulatory classifications including Drugs, Dietary Supplements, and Medical Devices.
* Knowledge of EU/EMEA regulatory frameworks and the ability to apply them throughout the product lifecycle.
* Strong understanding of regulatory CMC relevant to the markets.
* Excellent project management skills.
Company
Our client is a leading healthcare company dedicated to improving access, affordability, and creating healthier communities worldwide.
Location
This role is based at the client’s site in High Wycombe, with a hybrid work model of 2-3 days onsite per week.
Apply
Applicants must have the right to work in the UK. Please quote job reference 132033.
Note
This role may require a satisfactory DBS check.
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