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Cmc regulatory affairs consultant

High Wycombe
TN United Kingdom
Consultant
Posted: 6 May
Offer description

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CMC Regulatory Affairs Consultant, High Wycombe

Client:

CK Group

Location:

High Wycombe, United Kingdom


Job Category:

Consulting


EU work permit required:

Yes


Job Reference:

a7caa0ba948e


Job Views:

3


Posted:

26.04.2025


Expiry Date:

10.06.2025


Job Description:

CMC Regulatory Affairs Consultant

CK Group is recruiting for a CMC Regulatory Affairs Consultant to join a pharmaceutical company at their site in High Wycombe on a contract basis for 6 months.

Salary: £45-£62.93 per hour PAYE or £65-£84.55 per hour Umbrella.

Role Responsibilities:

* Developing CMC/technical regulatory strategies across the EMEA region.
* Leading a Regulatory Affairs team to ensure successful registration of new products, line extensions, and new indications and claims.
* Managing global or regional regulatory deliverables for drugs, dietary supplements, and medical devices as relevant.
* Building partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain, and local business teams.
* Representing the Regulatory Affairs CMC function in various franchise and leadership teams.

Candidate Requirements:

* Bachelor's Degree or equivalent experience in pharmaceutical CMC regulatory affairs.
* Experience with regulatory classifications including Drugs, Dietary Supplements, and Medical Devices.
* Understanding of EU/EMEA regulatory frameworks and ability to apply them across the product lifecycle.
* Strong knowledge of regulatory CMC in relevant markets.

Our client is a leading healthcare company committed to improving access, affordability, and creating healthier communities worldwide.

This role is based at the High Wycombe site, with a hybrid working model requiring 2-3 days on-site per week.

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