CMC Regulatory Affairs Consultant

TN United Kingdom; High Wycombe; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a CMC Regulatory Affairs Consultant to join their team in High Wycombe. This exciting role involves developing regulatory strategies and leading a team to ensure successful product registrations across the EMEA region. With a hybrid working model, you will collaborate with various departments to manage regulatory deliverables for drugs, dietary supplements, and medical devices. If you have a passion for regulatory affairs and want to make a difference in the healthcare sector, this opportunity is perfect for you.

Qualifications

• Experience in pharmaceutical CMC regulatory affairs is essential.
• Strong knowledge of regulatory classifications for drugs and medical devices.

Responsibilities

• Develop CMC regulatory strategies for the EMEA region.
• Lead a team to ensure successful product registrations.

Skills

Regulatory Affairs

CMC Regulatory Strategies

EU Regulatory Frameworks

Team Leadership

Education

Bachelor's Degree in Pharmaceutical Sciences

Job 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.