FUJIFILM Biotechnologies
Director Regulatory Affairs, UK
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Director Regulatory Affairs, UK
Director, Regulatory Affairs (UK)
Location: Billingham, UK
Join a growing, mission-driven biopharma organization at a pivotal moment.
About the Role
As Director, Regulatory Affairs (UK), you will:
- Lead the UK regulatory function, shaping the regional regulatory strategy
- Ensure seamless partner filings across key markets
- Partner closely with the Global Regulatory Affairs Leadership Team
Collaborate across sites and functions to enable compliant and efficient market access.
Responsibilities
-
People Management:
- Lead, mentor, and develop a high-performing Regulatory Affairs Team
- Embed a culture of excellence, clarity, and continuous improvement
-
Regulatory Strategy:
- Set and execute UK regulatory strategy aligned with global objectives
- Provide proactive regulatory intelligence to internal stakeholders and partners
-
Strategic Advisory:
- Serve as a senior regulatory advisor to project teams and customers
- Drive compliance and competitive positioning across the product lifecycle
-
External Agency Relations:
- Own external agency interactions in the UK (primarily MHRA), with engagement also required for EMA/FDA as relevant
- Build and maintain strong, constructive relationships; represent the business with integrity
-
Market & Filing Support:
- Guide and enable customer/partner filings for major markets (UK, EU, US), including:
- US Establishment Registration
- DMF Type V and FMA (Japan)
- 3.2(A) and SMF submissions
- Ensure submissions are ready and run smoothly
- Guide and enable customer/partner filings for major markets (UK, EU, US), including:
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
-
Regulatory Compliance &-Q Systems:
- Manage and advise on regulatory impacts within the Pharmaceutical Quality System (PQS), including:
- Compliance certificates, change controls, NCRs, ECNs, and CAPAs
- Support tier meetings and critical milestone deadlines
- Manage and advise on regulatory impacts within the Pharmaceutical Quality System (PQS), including:
-
Cross-functional Collaboration:
- Work closely with Process Sciences, Program Management, and PQS, or other partners
- Contribute to site expansions and authority engagement
Requirements
-
Education:
- BSc/MSc in a natural or life science discipline
-
Experience:
- Proven experience in Regulatory Affairs and/or Quality within the pharma/biotech industry
- Strong exposure to MHRA, EU, and US regulatory frameworks
- Demonstrated leadership of regulatory professionals and cross-functional influence
-
Technical Knowledge:
- Deep understanding of pharmaceutical legislation and regulatory agency engagements
- Expertise in filing pathways and product lifecycle compliance
-
Soft Skills:
- Excellent written and verbal communication
- Strong stakeholder management and problem-solving abilities
- Sound judgment with integrity, balancing business objectives and regulatory requirements
Benefits
- Strategic Impact: Global leadership scope with impact beyond the UK
- Innovation Focus: Shape regulatory frameworks for innovative programs and expansions
- Collaborative Culture: Values-driven environment with a focus on scientific rigor and customer success
Get help with your application
Your very own career expert that helps elevate your application to the next level.
Financial Package:
- Competitive salary
- 35 days holiday (excluding public holidays)
- Annual incentive plan
- Pension contribution: You contribute 4–9%+, with matching contributions from the company up to 7–12%, offering a total contribution of up to 21%
About FUJIFILM Biotechnologies
As part of the Fujifilm Group, our purpose is clear: “Giving our world more smiles.”
- We bring flexible, collaborative, and highly skilled individuals together to bring transformative solutions to life
- As Partners for Life, we seek to revolutionize biopharma through trust-based global partnerships
- Our global teams drive biologics, advanced therapies, and vaccines production across key geographies, supporting cutting-edge innovation in patient care and therapies
Commitment to Equality
Equal Opportunity Employer: We embed equality of opportunity in:
- Hiring, promotion, and advancement
- Compensation, benefits, and training
Our inclusive culture celebrates diversity in:
- Nationality, age, gender, sexual orientation/gender identity
- Race, ethnicity, religion, political creed, ideology
- National/social origin, disability, veteran status and more
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Skills