At a Glance
- Tasks: Lead and mentor a high-performing Regulatory Affairs team while shaping UK regulatory strategy.
- Company: Join a mission-driven biopharma organisation making a real impact in healthcare.
- Benefits: Competitive salary, 35 days holiday, annual incentives, and a strong pension plan.
- Other info: Collaborative culture focused on scientific rigor and customer success.
- Why this job: Shape regulatory frameworks for innovative programmes and enjoy global visibility.
- Qualifications: BSc/MSc in life sciences and experience in Regulatory Affairs within pharma/biotech.
The predicted salary is between 80000 - 100000 £ per year.
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.
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 and customer success.
- 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 or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc.
Director Regulatory Affairs, UK in Billingham employer: FUJIFILM Biotechnologies
Join a dynamic biopharma organisation in Billingham, UK, where you will play a pivotal role as the Director of Regulatory Affairs. This position offers a unique opportunity to lead a high-performing team within a collaborative and values-driven culture, focused on scientific excellence and customer success. With competitive benefits including 35 days of holiday, an attractive pension scheme, and a commitment to equal opportunities, this is an excellent employer for those seeking meaningful and impactful work in the regulatory landscape.
