Principal Regulatory Consultant

Barrington James; London; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

A leading global consultancy is seeking a Principal/Senior Consultant (CMC) in London to provide strategic regulatory guidance and support drug development projects. The role involves overseeing submissions, mentoring team members, and contributing to business growth. Candidates should possess extensive regulatory experience and strong leadership skills.

Qualifications

• Minimum of 8 years experience in drug development and regulatory affairs.
• Proven experience with FDA, EMA, and/or MHRA processes.
• Expertise in biologics, ATMPs, vaccines, or small molecules.

Responsibilities

• Develop innovative CMC regulatory strategies and drug development plans.
• Lead the preparation and review of regulatory documents.
• Mentor and manage junior team members.

Skills

Leadership

Organizational Skills

Time Management

Education

Advanced degree in life sciences (MSc or PhD preferred)

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 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.

To apply:

[e-mail]

Direct line: [phone]