Head of Regulatory Affairs
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.
Discover more about our Head of Regulatory Affairs opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
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
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
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