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- Tasks: Lead innovative CMC strategies and mentor junior experts in regulatory affairs.
- Company: Barrington James is a dynamic global consultancy focused on regulatory excellence.
- Benefits: Enjoy a hybrid work model with flexible hours and monthly office visits.
- Why this job: Shape the future of drug development while making a real impact in healthcare.
- Qualifications: 8-10 years in drug development, advanced degree preferred, and strong leadership skills required.
- Other info: Join a supportive team and contribute to exciting multi-jurisdictional projects.
The predicted salary is between 43200 - 72000 £ per year.
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 will 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: kwilson@barringtonjames.com Direct line: +44 1293 223 951
Contact Detail:
Barrington James Recruiting Team
kwilson@barringtonjames.com
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Regulatory Consultant
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with FDA, EMA, or MHRA processes. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in CMC strategies.
✨Tip Number 2
Showcase your leadership skills by discussing any mentoring or training experiences you've had in previous roles. Highlight how you’ve contributed to team development and business growth, as this aligns well with the responsibilities of the Principal Regulatory Consultant position.
✨Tip Number 3
Familiarise yourself with the specific regulatory challenges faced by clients in the biologics, ATMPs, and vaccine sectors. Being able to discuss these topics knowledgeably during interviews will demonstrate your expertise and readiness for the role.
✨Tip Number 4
Prepare to discuss your experience with multi-jurisdictional projects and how you’ve successfully navigated complex regulatory landscapes. This will be crucial in showcasing your ability to manage client relationships and oversee regulatory submissions effectively.
We think you need these skills to ace Principal Regulatory Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly focusing on CMC aspects. Emphasise your years of experience and any specific projects that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory consultancy and your ability to mentor others. Mention specific examples of how you've guided clients through complex regulatory landscapes.
Highlight Leadership Skills: Since the role involves mentoring junior team members, be sure to include examples of your leadership experience. Discuss how you've contributed to team development and business growth in previous roles.
Showcase Regulatory Knowledge: Demonstrate your understanding of FDA, EMA, and MHRA processes in your application. Include any relevant certifications or advanced degrees that support your expertise in biologics, ATMPs, or vaccines.
How to prepare for a job interview at Barrington James
✨Showcase Your Experience
With a minimum of 8 years in drug development and regulatory affairs required, be prepared to discuss your relevant experience in detail. Highlight specific projects where you developed CMC strategies or managed regulatory submissions.
✨Demonstrate Leadership Skills
As this role involves mentoring junior team members, share examples of how you've successfully led teams or provided training in the past. Discuss your approach to leadership and how you inspire others.
✨Stay Updated on Regulatory Trends
Make sure you're well-versed in the latest regulatory trends and changes, especially regarding FDA, EMA, and MHRA processes. Being able to discuss current events in the regulatory landscape will show your commitment to the field.
✨Prepare for Client Interaction Scenarios
Since you'll represent clients in regulatory agency interactions, think about potential scenarios you might face. Prepare to discuss how you would handle objections or negotiate outcomes effectively.
