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.
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 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.
Requirements
To apply:
kwilson@barringtonjames.com
Direct line: +44 1293 223 951