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- Tasks: Lead regulatory strategy to enhance patient access and commercial success across the UK and Europe.
- Company: Join a leading biopharmaceutical organisation dedicated to delivering safe and effective medicines.
- Benefits: Competitive salary, professional development, and the chance to influence regulatory frameworks.
- Other info: Dynamic role with opportunities for growth in a complex regulatory environment.
- Why this job: Shape the future of healthcare by driving impactful regulatory strategies and leading high-performing teams.
- Qualifications: Extensive experience in Regulatory Affairs and strong leadership skills required.
The predicted salary is between 75000 - 100000 £ per year.
Are you ready to lead regulatory strategy that shapes patient access and commercial success? Do you have the vision to influence regulatory frameworks and drive high impact outcomes across the UK and Europe? Can you build and lead a high performing team in a complex, evolving regulatory environment?
Fraser Dove International is partnering exclusively with a leading biopharmaceutical organisation. Operating in the United Kingdom, they are committed to delivering high quality, safe and effective medicines that address unmet patient needs. Our client is seeking a strategic leader to define and deliver regulatory strategy across a diverse product portfolio.
Your objectives:
- Develop and execute a forward looking regulatory strategy aligned to business goals, ensuring timely approvals and sustained compliance.
- Build and lead a high performing Regulatory Affairs function, strengthening capability, engagement and delivery.
- Influence regulatory policy and stakeholder relationships to support market access, innovation and long term growth.
What you will do:
- Lead and develop the UK Regulatory Affairs team, setting clear direction aligned with portfolio and global priorities.
- Define and oversee regulatory strategies for submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) and other relevant authorities.
- Ensure ongoing compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Quality Management Systems (QMS).
- Partner with cross functional teams including medical, commercial, supply chain and pricing to align regulatory strategy with business objectives.
- Represent Regulatory Affairs in senior leadership forums, providing insight and influencing decision making.
- Build and manage external stakeholder relationships, including health authorities and industry bodies.
- Drive operational excellence through process improvement, standardisation and change management initiatives.
What you will bring:
- Extensive experience in Regulatory Affairs within the pharmaceutical or life sciences industry.
- Strong knowledge of UK, Ireland and European Union regulatory frameworks.
- Proven leadership experience with the ability to build, develop and retain high performing teams.
- Demonstrated ability to develop and execute regulatory strategies aligned to commercial outcomes.
- Experience engaging with regulatory authorities and influencing external stakeholders.
- Degree in Pharmacy, Biology, Chemistry or a related Life Sciences discipline.
- Advanced qualifications are desirable.
Director of Regulatory Strategy in England employer: Fraser Dove International
Contact Detail:
Fraser Dove International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Strategy in England
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. Building relationships can open doors that applications alone can't.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory strategies. Show them you understand their goals and how you can help achieve them.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with their needs. Highlight your leadership skills and past successes in regulatory affairs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows your commitment to the role.
We think you need these skills to ace Director of Regulatory Strategy in England
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs. We want to see how your skills align with the specific objectives of the role, so don’t hold back on showcasing your relevant achievements!
Showcase Leadership Skills: Since this role is all about leading a high-performing team, be sure to emphasise your leadership experience. Share examples of how you've built and developed teams in complex environments, as this will really resonate with us.
Demonstrate Strategic Thinking: We’re looking for someone who can define and execute regulatory strategies. Use your application to illustrate your strategic mindset and how you’ve successfully influenced regulatory frameworks in the past.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at Fraser Dove International
✨Know Your Regulatory Landscape
Before the interview, brush up on the latest UK and EU regulatory frameworks. Be prepared to discuss how these regulations impact patient access and commercial success. Showing that you’re well-versed in current policies will demonstrate your expertise and readiness for the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've built and led high-performing teams in the past. Think about specific challenges you faced and how you overcame them. This will help illustrate your ability to lead the Regulatory Affairs function effectively.
✨Align with Business Objectives
Be ready to discuss how you would develop and execute a regulatory strategy that aligns with business goals. Think about past experiences where you successfully aligned regulatory strategies with commercial outcomes, and be prepared to share those insights.
✨Engage with Stakeholders
Demonstrate your experience in building relationships with external stakeholders, including health authorities. Prepare to talk about how you’ve influenced regulatory policy or engaged with industry bodies to support market access and innovation.