CMC Strategy Lead
4 days ago
Barrington James Limited is recruiting for a Principal/Senior Consultant (CMC) to join their dynamic and growing global consultancy in London.
This is a hybrid role with a flexible schedule and monthly office visits.
Job OverviewThe successful candidate will provide strategic and technical regulatory advice to clients, focusing on CMC aspects of product development.
Key Responsibilities- Develop comprehensive CMC regulatory strategies, identifying potential risks and gaps in current practices.
- Lead the preparation, authoring, and review of regulatory documents, ensuring accuracy and compliance.
- Represent clients in regulatory agency interactions, navigating complex regulatory landscapes.
- Manage project timelines, budgets, and deliverables, ensuring high-quality outcomes.
- Mentor and manage team members, fostering a culture of innovation and excellence.
- Contribute to business development through client relationships and identifying new opportunities.
- Stay up-to-date with regulatory trends and ensure compliance with evolving standards.
Salary: £95,000 - £115,000 per annum.
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.
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