Principle Regulatory CMC Consultant

About the job

The Company

Our client is a growing international regulatory and product development consultancy supporting pharmaceutical and biotechnology companies globally. They provide strategic expertise across CMC, regulatory affairs, and product development, helping clients progress products from early development through to approval.

The Role

This is a senior consultancy position for a CMC expert who can provide strategic regulatory and technical advice to clients across the pharmaceutical development lifecycle.

The successful candidate will combine strong scientific knowledge with regulatory expertise, supporting complex small molecule programmes and acting as a trusted advisor to clients.

Key Responsibilities

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• Provide CMC strategy and regulatory consultancy support for small molecule pharmaceutical programmes.
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• Develop regulatory strategies, development plans, and gap assessments.
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• Support preparation and review of regulatory documentation including INDs, CTAs, IMPDs, MAAs, NDAs, DMFs, and Health Authority responses.
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• Advise clients on CMC development, manufacturing strategy, scale-up, technology transfer, and lifecycle management.
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• Support FDA/EMA/MHRA and global regulatory interactions.
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• Lead client projects, stakeholder meetings, and provide technical leadership.
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• Mentor junior consultants and contribute to business development activities.
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Requirements

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• 10+ years’ experience in CMC development and/or CMC regulatory affairs for small molecule pharmaceuticals.
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• Strong background in small molecule NCE development, pharmaceutical manufacturing, and regulatory strategy.
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• Experience across areas such as process development, scale-up, technology transfer, formulation, analytical development, and lifecycle management.
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• Strong knowledge of FDA, EMA/MHRA requirements, ICH guidelines, and GMP regulations.
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• Experience supporting global regulatory submissions and health authority interactions.
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• Strong technical writing and communication skills.
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• MSc/PhD in a relevant scientific discipline preferred.
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• Consultancy or client-facing experience highly desirable.
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Experience across additional modalities (biologics, peptides, vaccines, biosimilars, advanced therapies, RNA/DNA therapeutics) would be advantageous.

Interested in this position? Apply now!

'09; [email protected]

&0E; +44 (0) 1293 77664