Principal Regulatory Consultant
Principal Regulatory Consultant
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Job Description
Job Description
Are you an experienced regulatory professional ready to take the lead in shaping innovative CMC strategies Barrington James is recruiting for a Principal/Senior Consultant (CMC) to join a dynamic and growing global consultancy. This is a hybrid role based in London United Kingdom with a flexible schedule and monthly office visits. If youre passionate about guiding clients through complex regulatory landscapes while mentoring the next generation of experts we want to hear from you!
*Minimum of 8 years experience required*
In this role youll provide strategic and technical regulatory advice to clients focusing on CMC (Chemistry Manufacturing and Controls) aspects of product development. Youll also oversee regulatory submissions guide multijurisdictional projects and manage client relationships. Additionally youll play a key role in mentoring junior team members and contributing to business development efforts.
Responsibilities
- Develop innovative CMC regulatory strategies gap analyses and drug development plans.
- Lead the preparation authoring and review of regulatory documents (INDs IMPDs MAAs etc..
- Represent clients in regulatory agency interactions addressing objections and negotiating outcomes.
- Oversee project timelines budgets and deliverables ensuring highquality outcomes.
- Mentor and manage team members providing training and technical leadership.
- Contribute to business development through client relationships and identifying new opportunities.
- Stay ahead of regulatory trends and ensure compliance with evolving standards.
Requirements
- Senior Consultant: 8 years in drug development and regulatory affairs.
- Principal Consultant: 10 years in drug development and regulatory affairs.
- Proven experience with FDA EMA and/or MHRA processes including submissions and negotiations.
- Expertise in biologics ATMPs vaccines or small molecules.
- Advanced degree in life sciences (MSc or PhD preferred).
- Strong leadership organizational and time management skills.
- Willingness to travel occasionally and work flexible hours.
To apply:
Direct line:
Required Experience:
Staff IC
Employment Type
Full-Time
