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- Tasks: Lead regulatory strategy to enhance patient access to innovative medicines.
- Company: Join a leading biopharmaceutical organisation committed to improving patient outcomes.
- Benefits: Generous salary, bonuses, company car allowance, and more.
- Other info: Opportunity to build high-performing teams in a dynamic environment.
- Why this job: Shape healthcare policy and make a real impact in the life sciences industry.
- Qualifications: Extensive Regulatory Affairs experience and strong leadership skills required.
The predicted salary is between 80000 - 100000 £ per year.
Are you ready to lead regulatory strategy that shapes patient access to innovative medicines? Do you have the vision to influence policy, regulatory frameworks, and business outcomes at a national level? Are you passionate about building and leading high-performing regulatory teams in a complex 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 improve patient outcomes. Our client is seeking a strategic leader to define and execute regulatory strategy while leading a high-performing Regulatory Affairs function.
Your objectives: As the Head of Regulatory Affairs, you will be measured against the following objectives:
- Deliver a robust regulatory strategy that ensures timely product approvals and lifecycle management aligned with business goals.
- Maintain full regulatory compliance and inspection readiness, ensuring adherence to all relevant regulatory standards and frameworks.
- Build and develop a high-performing Regulatory Affairs team while strengthening stakeholder engagement and influence.
What you will do: As the Head of Regulatory Affairs, your duties and responsibilities will include:
- Lead the development and execution of regulatory strategy across the UK portfolio, aligned with global and regional priorities.
- Provide oversight of high-quality submissions to regulatory authorities, including the Medicines and Healthcare products Regulatory Agency (MHRA).
- Represent Regulatory Affairs in senior leadership forums, providing strategic insight and guidance.
- Collaborate cross-functionally with medical, commercial, supply chain, and market access teams.
- Develop and lead external engagement strategies with health authorities and industry bodies.
- Drive continuous improvement through process optimisation, standardisation, and system enhancements.
- Lead change initiatives and ensure effective resource planning and budget management.
What you will bring: These are the skills and experience you will need to succeed as the Head of Regulatory Affairs:
- Extensive experience in Regulatory Affairs within the life sciences industry, including leadership responsibility.
- Strong knowledge of UK, Ireland, and European Union regulatory frameworks.
- Proven experience developing and executing regulatory strategies in a complex environment.
- Strong stakeholder management and influencing skills across senior leadership teams.
- Demonstrated leadership capability with experience building and developing high-performing teams.
- Degree in Pharmacy, Biology, Chemistry, or a related life sciences discipline.
- Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Quality Management Systems (QMS).
What you will get: These are the perks and benefits that will complement your generous base salary:
- Generous basic Salary
- Short Term Bonus
- LTI
- Company Car Allowance
Got what it takes? To apply for the Head of Regulatory Affairs, click the ‘Apply’ button below or contact the Executive Search Consultant – James Titchener-Hooker – on +44 (0)203 355 7050.
Head of Regulatory Affairs employer: Fraser Dove International
Contact Detail:
Fraser Dove International 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 help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory landscape. We want you to be able to discuss how your experience aligns with their goals, especially in shaping patient access to innovative medicines.
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've built high-performing teams and influenced stakeholders. We believe that demonstrating your capability can set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. We’re here to support you every step of the way in your job search journey.
We think you need these skills to ace Head of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Head of Regulatory Affairs role. Highlight your experience in regulatory strategy and team leadership, as these are key aspects of the job. We want to see how your background aligns with the objectives outlined in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our mission. Be sure to mention specific experiences that demonstrate your ability to lead high-performing teams and influence policy.
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just responsibilities. Use metrics where possible to illustrate your impact, like successful product approvals or improvements in compliance. We love seeing how you've made a difference!
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It streamlines the process for us and ensures your application gets to the right people. Don’t miss out on this opportunity to join our team!
How to prepare for a job interview at Fraser Dove International
✨Know Your Regulatory Frameworks
Make sure you brush up on your knowledge of UK, Ireland, and EU regulatory frameworks. Be prepared to discuss how these regulations impact the biopharmaceutical industry and how you can navigate them effectively.
✨Showcase Your Leadership Skills
As a candidate for the Head of Regulatory Affairs, it's crucial to demonstrate your leadership capabilities. Prepare examples of how you've built and developed high-performing teams in the past, and be ready to discuss your approach to stakeholder management.
✨Prepare for Strategic Discussions
Expect to engage in conversations about regulatory strategy and its alignment with business goals. Think about how you would lead the development and execution of such strategies, and be ready to share your vision for influencing policy at a national level.
✨Highlight Continuous Improvement Initiatives
Be ready to talk about your experience with process optimisation and system enhancements. Discuss specific initiatives you've led that have driven continuous improvement in regulatory affairs, showcasing your ability to adapt and innovate in a complex environment.