CMC Regulatory Affairs Consultant

CK Group; High Wycombe; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

An established industry player in the pharmaceutical sector is seeking a CMC Regulatory Affairs Consultant for a 6-month contract. This role involves developing regulatory strategies across EMEA, managing global regulatory deliverables, and leading a dedicated team to ensure the successful registration of new products. The position offers a hybrid work model, allowing you to balance on-site and remote work. If you have a strong background in regulatory affairs and project management, this opportunity could be the next step in your career.

Qualifications

• Experience with regulatory classifications including Drugs, Dietary Supplements, and Medical Devices.
• Strong understanding of regulatory CMC relevant to the markets.

Responsibilities

• Develop CMC/technical regulatory strategies across the EMEA.
• Lead a Regulatory Affairs team to ensure successful registration of products.

Skills

Regulatory Affairs

Project Management

Knowledge of EU/EMEA regulatory frameworks

Education

Bachelor’s Degree in Pharmaceutical CMC Regulatory Affairs

Job description

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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