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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 career 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: As the Head of Regulatory Affairs, you will be measured against the following 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.
Please Note: This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job related instructions and to perform any other job related duties requested by any person authorised to give instructions or assignments.
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Director of Regulatory Strategy 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
✨Tip Number 1
Network like a pro! Get out there and connect with industry professionals on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream role.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory strategies. We recommend practising common interview questions and having your own questions ready to show your interest and insight into their operations.
✨Tip Number 3
Showcase your leadership skills! When discussing your experience, highlight how you've built and led teams in the past. We want to see how you can drive high performance in a complex environment.
✨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. Plus, we’re always looking for top talent to join our network.
We think you need these skills to ace Director of Regulatory Strategy
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to reflect the specific skills and experiences that align with the Director of Regulatory Strategy role. Highlight your leadership experience and knowledge of regulatory frameworks to show us you’re the perfect fit!
Showcase Your Achievements: Don’t just list your responsibilities; we want to see your impact! Use quantifiable achievements to demonstrate how you've influenced regulatory strategies or led high-performing teams in the past. This will help us understand the value you can bring.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key messages stand out. This will make it easier for us to see your qualifications at a glance.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details directly and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Fraser Dove International
✨Know Your Regulatory Frameworks
Make sure you brush up on the UK, Ireland, and EU regulatory frameworks. Being able to discuss specific regulations and how they impact the biopharmaceutical industry will show that you're not just familiar with the basics but are ready to lead in this complex environment.
✨Showcase Your Leadership Skills
Prepare examples of how you've built and led high-performing teams in the past. Highlight your ability to engage and develop team members, as well as how you've driven operational excellence through process improvements. This is crucial for the role!
✨Align with Business Objectives
Be ready to discuss how you can align regulatory strategies with commercial outcomes. Think about past experiences where your regulatory decisions directly influenced market access or product success, and be prepared to share those stories.
✨Engage with Stakeholders
Demonstrate your experience in building relationships with external stakeholders, including health authorities and industry bodies. Prepare to talk about how you've influenced regulatory policy or navigated complex stakeholder environments to achieve successful outcomes.