ROLE OVERVIEW
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.
WHATS 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.....Read more...
