At a Glance
- Tasks: Lead regulatory strategies and a skilled team in the pharmaceutical sector.
- Company: Innovative pharmaceutical company focused on patient-centric healthcare solutions.
- Benefits: Competitive salary, leadership role, and opportunity to shape healthcare access.
- Why this job: Make a real impact on patient care and drive regulatory excellence.
- Qualifications: Advanced degree in life sciences and extensive experience in regulatory affairs.
- Other info: Join a dynamic team with opportunities for growth and innovation.
The predicted salary is between 72000 - 108000 ÂŁ per year.
Head of Regulatory Affairs – UK & Ireland
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.
Key Responsibilities
- Lead a team of 12 professionals in regulatory strategy and execution across the pharmaceutical portfolio.
- Shape and implement bold, forward-looking regulatory strategies for the UK and Ireland.
- Drive innovative and sustainable regulatory solutions that enable timely and optimal product access.
- Oversee early development, pre-launch, and lifecycle management activities, including high‑profile launches over the next three years.
- Align regulatory strategy with the company’s long‑term objectives, therapeutic area priorities, and patient care mission.
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, Commercial and Marketing
- 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
Contact
- By phone: +44 (0)1273 059 648 or +44 (0) 7881 555 382
Job Details
- Seniority Level: Executive
- Employment Type: Full-time
- Job Function: Management
- Industry: Biotechnology Research and Pharmaceutical Manufacturing
- Location: London, England, United Kingdom
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Head of Regulatory Affairs employer: Haybury
Contact Detail:
Haybury Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. We all know that sometimes it’s not just what you know, but who you know that can get you in the door.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. We want to show that you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute to their success.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Head of Regulatory Affairs. We need to highlight your leadership skills and strategic vision clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see how you can help shape the future of healthcare solutions with us.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your leadership experience and any relevant regulatory affairs achievements to show us you’re the perfect fit for this role.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you’re passionate about regulatory affairs and how your vision aligns with our mission. Be bold and let your personality come through!
Showcase Your Achievements: When detailing your experience, focus on quantifiable achievements. Did you lead a successful HTA submission? Share the results! We love seeing how you’ve made an impact in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us during the process!
How to prepare for a job interview at Haybury
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines in the pharmaceutical industry, especially those relevant to the UK and Ireland. Being able to discuss recent changes or challenges in regulatory affairs will show that you're not just knowledgeable but also passionate about the field.
✨Showcase Your Leadership Skills
As a Head of Regulatory Affairs, you'll be leading a team. Prepare examples of how you've successfully managed teams in the past, particularly in high-pressure situations. Highlight your ability to inspire and drive results, as this will resonate well with the interviewers.
✨Understand the Market Landscape
Familiarise yourself with the current market access strategies and pricing models used in the UK and Ireland. Be ready to discuss how you would approach these areas for the company’s portfolio, demonstrating your strategic thinking and understanding of the healthcare system.
✨Prepare Thoughtful Questions
Interviews are a two-way street! Prepare insightful questions about the company's future plans, their approach to regulatory challenges, and how they envision the role evolving. This shows your genuine interest in the position and helps you assess if it's the right fit for you.