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 you're 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, you'll provide strategic and technical regulatory advice to clients, focusing on CMC (Chemistry, Manufacturing, and Controls) aspects of product development.
You'll also oversee regulatory submissions, guide multi-jurisdictional projects, and manage client relationships.
Additionally, you'll play a key role in mentoring junior team members and contributing to business development efforts.
ResponsibilitiesDevelop 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 high-quality 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.RequirementsSenior 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: +44 1293 223 951
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