Regulatory Affairs Consultant, CMC

JR United Kingdom; High Wycombe; On-site; GBP 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Consultant to drive regulatory strategies across the EMEA region. This exciting role involves leading a team to ensure successful product registrations and collaborating with cross-functional teams. The ideal candidate will have a strong background in pharmaceutical CMC regulatory affairs, excellent communication skills, and the ability to navigate complex regulatory frameworks. Join this dynamic environment and contribute to impactful projects in consumer health, where your expertise will shape the future of product development.

Qualifications

• Bachelor's Degree or higher in a relevant field.
• Broad expertise in regulatory classifications including Drugs, Dietary Supplements, and Medical Devices.

Responsibilities

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

Skills

Regulatory Affairs

Technical Guidance

Communication Skills

Regulatory Strategy Development

Education

Bachelor's Degree

Job description

Regulatory Affairs Consultant, CMC, High Wycombe

PE Global is currently recruiting for a Regulatory Affairs Consultant, CMC for a leading multinational consumer health company in High Wycombe.

This is a 6-month contract role paying £75-85 per hour via Umbrella. Inside IR35.

Responsibilities

• Develop CMC/technical regulatory strategies across the EMEA region, providing regulatory input and technical guidance on regional requirements to product development teams within the Self Care franchise.
• Lead a Regulatory Affairs team to ensure successful registration of new products, line extensions, and new indications and claims, with technical justification/documentation aligned with the business plan.
• Create operational excellence through regulatory expertise by managing direct reports and collaborating with cross-functional teams to meet regulatory objectives.
• Manage global and regional regulatory deliverables for drugs, dietary supplements, and medical devices within their brand and geographic responsibilities.
• Build strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain, and local business teams.
• Represent the Regulatory Affairs CMC function in the Self Care Franchise, and in functional and business leadership teams.

Qualifications and Experience

• Bachelor's Degree or higher in a relevant field.
• Broad expertise across regulatory classifications including Drugs, Dietary Supplements, and Medical Devices, with a focus on pharmaceutical CMC regulatory affairs.
• Knowledge of EU and wider EMEA regulatory frameworks and the ability to apply them throughout the product lifecycle.
• Strong understanding of regulatory CMC in relevant markets.
• Proficiency in English.
• Excellent communication skills, capable of articulating complex regulatory or technical concepts clearly and persuasively in both verbal and written form.

Interested candidates should submit an updated CV. Please apply via the link below or send your CV to [emailprotected].

***Note: Our client cannot assist with visa sponsorship; candidates must have the appropriate visa to live and work in the UK.***