Director of Regulatory Strategy

Fraser Dove International; Greater London; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical organisation in the United Kingdom seeks a strategic leader for Regulatory Affairs to build a high-performing team and drive regulatory strategies aligned with business goals. The role involves overseeing submissions to health authorities, ensuring compliance with regulations, and influencing stakeholder relationships to support market access. Candidates should have extensive experience in Regulatory Affairs, strong knowledge of UK and EU frameworks, and hold a degree in a relevant life sciences discipline.

Qualifications

• Extensive experience in Regulatory Affairs within the pharmaceutical or life sciences industry.
• Strong knowledge of UK regulatory frameworks.
• Demonstrated ability to develop regulatory strategies.

Responsibilities

• Lead and develop the UK Regulatory Affairs team.
• Define and oversee regulatory strategies for submissions.
• Ensure compliance with GMP, GDP, and QMS.

Skills

Extensive experience in Regulatory Affairs

Strong knowledge of UK and EU regulatory frameworks

Proven leadership experience

Ability to build high performing teams

Experience engaging with regulatory authorities

Education

Degree in Pharmacy, Biology, Chemistry or related Life Sciences

Advanced qualifications

Job description

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.

Additional Information:

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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