Head of Regulatory Affairs

Head of Regulatory Affairs

An outstanding opportunity has arisen within a leading, innovation-driven pharmaceutical company dedicated to delivering value-based, patient-centric healthcare solutions. As Head of Regulatory Affairs for the UK and Ireland, you will play a pivotal role on the Leadership Team, shaping and executing bold, forward-looking regulatory strategies across the entire pharmaceutical portfolio.

In this influential position, you will lead a highly skilled team of 12 professionals, driving innovative and sustainable regulatory solutions that enable timely and optimal product access. Working across early development, pre-launch, and lifecycle management, you will oversee a significant number of high-profile launches planned over the next three years. This is a rare opportunity for a strategic and visionary leader to shape the future of access in the UK and Ireland, ensuring that regulatory strategies not only enable market success but also deliver lasting value for patients.

Your approach will align closely with the company’s long-term objectives, therapeutic area priorities, and overarching mission to advance patient care, ultimately driving both regulatory excellence and sustainable business growth in a dynamic and evolving healthcare landscape.

Job Requirements:

• A degree in life sciences, health economics, epidemiology, or postgraduate qualification (e.g., MSc, PhD) in Health Economics, Market Access, or Public Health
• Long-term experience in, and demonstrated understanding of the pharmaceutical/biotech industry, managing prescription and innovative medicine
• Extensive experience focused on Market Access, Pricing, Contracting, Sales, Commerical and Marketing
• A comprehensive and in-depth understanding of the UK and Ireland healthcare systems, with expertise in navigating the complexities of Health Technology Assessment (HTA) processes, payer bodies, and reimbursement systems, including familiarity with key players, policy frameworks
• Proven track record of leading HTA submissions and executing competitive pricing models and commercial contracts with the NHS
• Comfortable building and adapting strategies across pre-launch, launch, and post-launch access stages, with proven experience in both pre- and post-launch phases
• Experience in Leadership and Team Management: Experience in managing direct reports (not just cross-functional leadership)

Education:

• Master’s degree or equivalent in Pharmacy or Life Sciences.
• Advanced qualifications such as a PhD, MD, PharmD, Specialised Pharmacist, or Master’s in Drug Regulatory Affairs are highly valued
• Vast experience in the life sciences and/or pharmaceutical industry, focused to Regulatory Affairs, with strong national experience for UK and Ireland
• Comprehensive understanding of the global drug development process, regulatory frameworks, and procedures covering product development, submission, and lifecycle management
• Proven experience in direct interactions with Health Authorities, supporting Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), variations, renewals, and related submissions
• Several years of experience in leading international and cross-functional project teams, as well as direct leadership of Regulatory Affairs team leads and managers
• In-depth knowledge of local regulatory requirements, including the ability to interpret and apply complex legislation effectively

If you are an inspiring leader with a passion for innovation, we encourage you to apply early.

If you have the skills and experience for this opportunity and the ambition to take on this position, please contact Vicki for further details or email your CV today.

• By email:
• By phone: +44 (0)1273 059 648 or +44 (0) 7881 555 382