CMC Regulatory Affairs Executive

London

3 months ago

Applications closed

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CMC Regulatory Consultant - Permanent

Regulatory Affairs Specialist

CMC Regulatory Affairs Executive

Location: Hybrid based at either Hertfordshire or London

Employment Type: 12 Month Contract - 37.5 hours per week.

Pay Rate: £582.41 p/d Umbrella

Are you ready to take the lead on shaping regulatory strategy for cutting-edge small-molecule development? This is an exciting opportunity to step into a high-impact role where your expertise in CMC regulatory affairs will drive global submissions, accelerate development timelines, and support the successful launch of innovative medicines.

At CY Partners, we’re supporting a world-class pharmaceutical organisation in the search for a proactive, insightful and collaborative CMC Regulatory Affairs Executive. This position sits within a dynamic team focused on delivering regulatory strategies across multiple development programmes.

The Opportunity

In this role, you’ll take ownership of global CMC regulatory strategies, guiding teams through the evolving regulatory landscape and ensuring high-quality submissions across early development and lifecycle stages. You’ll work cross-functionally, influence scientific and operational decisions, and play a key part in supporting supply continuity and product availability worldwide.

Key Responsibilities

Lead the CMC strategy for global and regional submissions, ensuring alignment with scientific, regulatory and quality expectations.

Ensure all required CMC regulatory submissions are delivered accurately and on time to support rapid launch and uninterrupted market supply.

Take accountability for high-quality submission packages that meet regional requirements and minimise follow-up questions.

Provide clear guidance on global regulations, evolving guidelines and best practices across development and manufacturing.

Identify regulatory risks and propose robust mitigation strategies.

Deliver strategic CMC input during major inspections or quality events.

Manage and prioritise activities across multiple complex projects simultaneously.

Evaluate regulatory processes and contribute ideas to strengthen efficiency, quality and compliance.

About You

You’ll bring a blend of technical depth, regulatory insight and strong communication skills. Someone who can influence, challenge and guide diverse teams with confidence.

Essential:

Bachelor’s degree in a scientific discipline.

Strong experience in regulatory affairs.

Solid understanding of drug development, manufacturing and supply chains.

Proven ability to negotiate with regulatory authorities and industry partners.

Hands-on experience with major filing activities (e.g., MAA, NDA, BLA, significant manufacturing changes, or key early-development submissions).

Desirable:

MSc or PhD in a relevant field.

Background in pharmaceutical or vaccine development.

Extensive experience developing and executing complex regulatory strategies.

Strong interpersonal, presentation and written communication skills.

Ability to navigate a highly matrixed organisation and build strong internal networks

If this sounds interesting to you apply now with a copy of your CV

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