Principal Regulatory Consultant

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 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
 

• 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.