Director, Regulatory Affairs (UK)
Location: Billingham, UK. Join a growing, mission-driven biopharma organization 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, driving 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 and represent the business with integrity.
- Guide and enable customer/partner filings for major markets (UK, EU, US), ensuring readiness and smooth submissions (e.g., US Establishment Registration, DMF Type V, FMA Japan, 3.2.A, SMF).
- Oversee and advise on regulatory impact within the Pharmaceutical Quality System (e.g., compliance certificates, change controls, NCRs, ECN, CAPAs), and support tier meetings and key milestones.
- Collaborate closely with Process Sciences, Program Management, PQS, and other partners to co-develop solutions and support site expansions and authority engagement.
What you’ll bring
- BSc/MSc in a natural or life science discipline.
- Experience in Regulatory Affairs and/or Quality within pharma/biotech, including 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.
Benefits
Competitive salary, with 35 days holiday (not including public holidays), annual incentive plan and competitive pension: you contribute 4-9%+ and we contribute 7-12% (up to 21% total), with flexible investment/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, gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. We are part of the Fujifilm Group, and we all share the same purpose.
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