At a Glance
- Tasks: Lead global regulatory strategies for cutting-edge cell and gene therapies.
- Company: Join a leading CDMO known for advanced therapies and biologics manufacturing.
- Benefits: Executive visibility, direct client partnerships, and influence in innovative life sciences.
- Why this job: Shape the future of regulatory strategy in a rapidly growing field.
- Qualifications: Degree in Life Sciences and extensive regulatory affairs experience required.
- Other info: Be part of a dynamic leadership team driving excellence in Cell and Gene Therapy.
The predicted salary is between 72000 - 108000 £ per year.
ROLE OVERVIEW
Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
An exciting opportunity for a VP, Global Regulatory Affairs to join a leading Cell and Gene Therapy CDMO. As the VP, Global Regulatory Affairs, you will play a key role in providing global regulatory leadership, supporting clients developing advanced therapy programmes from early development through to commercialisation.
You will be responsible for defining and implementing global regulatory strategies, ensuring compliance with international standards, and building strong partnerships with regulatory authorities. This role reports directly into the SVP, Global Quality and will lead an experienced regulatory team during a period of continued international growth.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the VP, Global Regulatory Affairs will be varied however the key duties and responsibilities are as follows:
Develop and execute global regulatory strategies that support client programmes across cell and gene therapy, ensuring alignment with regional and international agency expectations.
Act as the senior regulatory representative with global health authorities, leading discussions, responses, and inspections while building trusted long-term relationships.
Provide expert regulatory input across CMC, clinical, and post-approval activities, supporting high-quality submissions such as INDs, IMPDs, and variations.
Partner with commercial, quality, and technical operations teams to provide regulatory insight during client engagements, business development activities, and due diligence reviews.
Lead, coach, and mentor a high-performing global regulatory team, fostering collaboration, accountability, and professional development across regions.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the VP, Global Regulatory Affairs we are looking to identify the following on your profile and past history:
A Degree or higher level in a relevant Life Science discipline (e.g., Pharmaceutical Chemistry / Biochemistry / Regulatory Science).
Extensive experience in global regulatory affairs within biologics, advanced therapy, or gene therapy environments.
Proven leadership experience within a CDMO or partnering organisation, managing regulatory teams and engaging with global health authorities.
Demonstrated ability to lead strategic regulatory initiatives, ensuring compliance and supporting clients through the product lifecycle.
WHAT’S IN IT FOR YOU?
You will join a business recognised for its expertise in advanced therapies and biologics manufacturing, with the opportunity to shape global regulatory strategy across a growing international network. This position offers visibility at executive level, direct involvement in client partnerships, and the chance to influence regulatory direction in one of the most innovative areas of life sciences. You will be part of the senior leadership team driving excellence in Cell and Gene Therapy development.
KEY WORDS: VP Global Regulatory Affairs / Regulatory Affairs / Advanced Therapy / Gene Therapy / Biologics / ATMP / CGT / CDMO / CMC / FDA / EMA / MHRA / Leadership / Compliance / Regulatory Strategy / Quality Systems / Biotechnology
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career
VP Global Regulatory employer: Hyper Recruitment Solutions LTD
Contact Detail:
Hyper Recruitment Solutions LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land VP Global Regulatory
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant conferences. Building relationships can open doors that a CV alone can't.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory landscape. Show them you know your stuff about cell and gene therapy and how it fits into their mission.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with their needs, especially in global regulatory affairs. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace VP Global Regulatory
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in global regulatory affairs, especially in biologics and advanced therapies. We want to see how your background aligns with the key duties mentioned in the job description.
Showcase Leadership Skills: Since this role involves leading a regulatory team, don’t forget to showcase your leadership experience. Share examples of how you've mentored teams or led strategic initiatives in your previous roles.
Highlight Regulatory Expertise: Be specific about your expertise in regulatory submissions like INDs and IMPDs. We’re looking for candidates who can demonstrate their knowledge of compliance and regulatory strategies across different regions.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨Know Your Regulatory Stuff
Make sure you brush up on the latest trends and regulations in cell and gene therapy. Familiarise yourself with key regulatory bodies like the FDA, EMA, and MHRA, and be ready to discuss how these impact global strategies.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing regulatory teams. Think about times when you successfully led discussions with health authorities or mentored team members, as this will resonate well with the interviewers.
✨Align with Company Goals
Research the company’s mission and recent projects. Be ready to explain how your vision for global regulatory affairs aligns with their goals, particularly in advanced therapies. This shows you’re not just a fit for the role but also for the company culture.
✨Prepare for Scenario Questions
Expect scenario-based questions where you’ll need to demonstrate your problem-solving skills. Think of potential challenges in regulatory compliance and how you would address them, showcasing your strategic thinking and expertise.