FUJIFILM Biotechnologies
Director Regulatory Affairs, UK
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Director Regulatory Affairs, UK
Director, Regulatory Affairs (UK)
Location: Billingham, UK
Join a growing, mission-driven biopharma organisation at a pivotal moment. As Director, Regulatory Affairs (UK), you will lead the UK regulatory function, shape regional regulatory strategy, and ensure seamless partner filings across major markets. You’ll be a key member of the Global Regulatory Affairs leadership team, partnering across sites and functions to enable compliant, efficient market access.
What You’ll Do
- Lead, mentor, and develop a high-performing Regulatory Affairs team
- Embed a culture of excellence, clarity, and continuous improvement
- Set and execute UK regulatory strategy, aligned to global objectives
- Provide proactive regulatory intelligence to internal stakeholders and partners
- Serve as a senior regulatory advisor to project teams and customers
- Drive compliance and competitive positioning across the product lifecycle
- Own external agency interactions in the UK (primarily MHRA; also EMA/FDA as relevant)
- Build strong, constructive relationships with agencies
- Represent the business with integrity
- Guide and enable customer/partner filings for major markets (UK, EU, US)
- Ensure readiness and smooth submissions for regulatory pathways such as:
- US Establishment Registration
- DMF Type V
- FMA (Japan)
- 3.2.A (EU Rapid Response)
- Single Master File (SMF)
- Ensure readiness and smooth submissions for regulatory pathways such as:
- Oversee and advise on regulatory impact within the Pharmaceutical Quality System (PQS)
- Compliance certificates, change controls, Non-Conformance Reports (NCR), ECNs
- Corrective and Preventive Actions (CAPAs)
- Support key regulatory tier meetings and critical milestones
- Collaborate closely with Process Sciences, Program Management, PQS, and other partners
- Co-develop solutions
- Support site expansions and authority engagement
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What You’ll Bring
- BSc/MSc in a natural or life science discipline
- Experience in Regulatory Affairs and/or Quality within pharma/biotech
- Strong exposure to MHRA, EU, and US regulatory frameworks
- Proven leadership of regulatory professionals and cross-functional influence
- Deep knowledge of pharmaceutical legislation, regulatory agency engagement, and filing pathways
- Strong written and verbal communication, stakeholder management, and problem-solving skills
- Sound judgment and integrity in balancing business objectives with regulatory requirements
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Why Join?
- Strategic leadership scope with global visibility and impact
- Opportunity to shape regulatory frameworks for innovative programs and expansions
- Collaborative, values-driven culture focused on:
- Scientific rigor
- Customer success
- Competitive benefits package:
- Competitive salary
- 35 days holiday (excluding public holidays)
- Annual incentive plan
- Flagsight pension: you contribute 4–9%+ (auto-enrolment default), and we contribute 7–12% (up to 21% total combined)
- Flexible investment and retirement options
Equal Opportunity Employer We are committed to equal opportunities in hiring, promotion, advancement, compensation, benefits, and training regardless of:
- Nationality
- Age
- Gender
- Sexual orientation or gender identity
- Race
- Ethnicity
- Religion
- Political creed
- Ideology
- National or social origin
- Disability
- Veteran status
- Or any other protected characteristic
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