At a Glance
- Tasks: Provide strategic regulatory consultancy for small molecule pharmaceutical programmes.
- Company: A growing international consultancy supporting pharma and biotech companies globally.
- Benefits: Competitive salary, professional development, and opportunities to mentor junior consultants.
- Other info: Exciting opportunity to lead projects and interact with global health authorities.
- Why this job: Join a dynamic team and make a real impact in pharmaceutical development.
- Qualifications: 10+ years in CMC development, strong scientific and regulatory expertise required.
The predicted salary is between 80000 - 100000 £ per year.
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
- Provide CMC strategy and regulatory consultancy support for small molecule pharmaceutical programmes.
- Develop regulatory strategies, development plans, and gap assessments.
- Support preparation and review of regulatory documentation including INDs, CTAs, IMPDs, MAAs, NDAs, DMFs, and Health Authority responses.
- Advise clients on CMC development, manufacturing strategy, scale-up, technology transfer, and lifecycle management.
- Support FDA/EMA/MHRA and global regulatory interactions.
- Lead client projects, stakeholder meetings, and provide technical leadership.
- Mentor junior consultants and contribute to business development activities.
Requirements
- 10+ years’ experience in CMC development and/or CMC regulatory affairs for small molecule pharmaceuticals.
- Strong background in small molecule NCE development, pharmaceutical manufacturing, and regulatory strategy.
- Experience across areas such as process development, scale-up, technology transfer, formulation, analytical development, and lifecycle management.
- Strong knowledge of FDA, EMA/MHRA requirements, ICH guidelines, and GMP regulations.
- Experience supporting global regulatory submissions and health authority interactions.
- Strong technical writing and communication skills.
- MSc/Ph D in a relevant scientific discipline preferred.
- Consultancy or client-facing experience highly desirable.
Experience across additional modalities (biologics, peptides, vaccines, biosimilars, advanced therapies, RNA/DNA therapeutics) would be advantageous.
Interested in this position? Apply now!
☎ +44 (0) 1293 77664
Principle Regulatory CMC Consultant in London employer: Barrington James
As a Quality Control Scientist in our leading pharmaceutical/biotech QC laboratory, you will thrive in a collaborative team environment that prioritises scientific excellence and compliance with GMP standards. We offer competitive day rates and the opportunity to enhance your skills in microbiology and quality control testing, ensuring your professional growth in a fast-paced and regulated setting.
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We think you need these skills to ace Principle Regulatory CMC Consultant in London
Some tips for your application 🫡
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