Albion Rye Associates
Director Regulatory Strategy
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Director Regulatory Strategy
Hybrid - London
Salary Banding: £120,000-£150,000
We are supporting a growing life sciences organisation in the appointment of a Director of Regulatory Strategy.
This is a senior leadership opportunity for an experienced regulatory professional to take strategic ownership of regulatory activities and medical writing, while supporting the continued growth, development and operational excellence of these functions.
The Role
The Director will provide strategic leadership across Regulatory and Medical Writing, ensuring the delivery of high-quality, compliant regulatory submissions and scientific documentation.
The successful candidate will act as a senior regulatory expert across early clinical development, provide strategic advice to clients and internal teams, and play a key role in strengthening regulatory capability, processes and service delivery.
You will also contribute to business development, sponsor relationships and the organisation's broader scientific and regulatory strategy.
Key Responsibilities
Leadership & Strategy
- Provide senior regulatory expertise across early clinical development.
- Chair and lead an Expert Regulatory Advisory Board, leveraging external expertise to support strategic clinical development and regulatory decision-making.
- Provide strategic leadership across Regulatory and Medical Writing.
- Lead, develop and structure teams to ensure high-quality delivery and scalability.
- Establish clear accountability for outcomes, performance and professional standards.
- Drive capability development, operational efficiency and continuous improvement.
- Work closely with Clinical Project Delivery, Commercial and Quality Assurance teams.
- Take accountability for departmental performance against business objectives.
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Regulatory
- Develop and execute regulatory strategies and services for client organisations.
- Lead regulatory submissions and provide strategic regulatory advice.
- Provide expertise on innovative regulatory pathways, including ILAP.
- Support business development activities, including client calls and bid defence meetings.
- Monitor regulatory and guideline developments and advise senior management on their implications.
- Ensure regulatory activities remain compliant with applicable requirements and guidance.
- Advise project teams on regulatory aspects of clinical trials and early clinical development.
- Support the preparation and review of regulatory submissions, ensuring accuracy and regulatory appropriateness.
- Oversee regulatory filing and tracking activities.
- Lead engagement with regulatory bodies, government agencies and other relevant stakeholders.
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About You
You will ideally have:
- Significant experience in regulatory affairs, ideally within clinical development.
- Strong leadership and strategic planning experience, including coaching and mentoring multidisciplinary teams.
- Deep expertise in regulatory frameworks and clinical development.
- Proven experience writing and reviewing key regulatory documentation, including Clinical Trial Applications (CTAs), Investigational New Drug Applications (INDs) and Scientific Advice requests.
The Opportunity
This is an opportunity to join an organisation where you will have significant influence over regulatory strategy, scientific quality, team development and client delivery.
If you are an experienced regulatory leader looking for a role combining strategic leadership, technical expertise, client engagement and team development, we'd be interested in hearing from you.
Competitive salary + benefits, including private medical, private dental, pension, 25 days' annual leave plus bank holidays and more.
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