Director, Regulatory Strategy Lead Europe

1010 Celgene - Summit (Corp); Uxbridge; Hybrid; GBP 180,000 - 240,000; Full time

Job summary

Bristol Myers Squibb is seeking a Director, European Regulatory Strategy Lead to shape strategy across Immunology & Cardiovascular medicines. You’ll guide development, registration, and lifecycle plans, negotiating with EMA and authorities to achieve timely approvals across Europe.

This senior role requires strategic thinking, collaboration across functions, and a strong regulatory track record. Based in Europe with hybrid work options, you will influence cross-border teams and external

Qualifications

• Strong scientific/medical background across regulatory affairs.
• Experience delivering global/EU regulatory strategies.
• Immunology and/or cardiovascular exposure preferred.
• Track record of Health Authority negotiations (EMA).
• Experience leading cross-functional matrix teams.
• Excellent written and verbal communication skills.

Responsibilities

• Define and drive EU regulatory strategy across development, registration, and lifecycle management.
• Lead negotiations with the EMA and Health Authorities, translating strategy into outcomes.
• Build integrated submission plans and translate into deliverables for internal/external teams.
• Integrate scientific, medical, legal and business perspectives for regulatory outcomes.
• Provide regulatory guidance to Development Team Leaders and stakeholders.
• Monitor evolving European/international regulatory trends and position ahead of curve.
• Build relationships with Health Authorities, alliance partners, and EU colleagues.

Skills

Regulatory strategy

Leadership

Cross-functional

Communication

Regulatory negotiations

Education

PhD/MD/PharmD/MSc/BSc

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Shape the Future of Immunology & Cardiovascular Medicine

Are you a seasoned regulatory strategist ready to drive cutting-edge medicines through the European approval landscape? At BMS, we're looking for a bold, scientifically grounded Director, European Regulatory Strategy Lead to champion our Immunology & Cardiovascular (ICV) portfolio — from early development all the way through registration and lifecycle management. This is your opportunity to sit at the heart of strategy, directly influencing how transformative therapies reach patients across Europe.

What You'll Do

• Define and drive EU regulatory strategy across development, registration, and lifecycle management
• Lead negotiations with the EMA and other relevant Health Authorities, translating BMS strategy into real outcomes
• Build integrated submission plans and translate them into operational deliverables for internal teams and external partners
• Integrate scientific, medical, legal and business perspectives to achieve optimal regulatory outcomes
• Provide authoritative regulatory guidance to Development Team Leaders and cross-functional stakeholders, proactively resolving complex issues
• Monitor and anticipate evolving European and international regulatory trends, positioning BMS ahead of the curve
• Build and nurture strong relationships with Health Authorities, alliance partners, and EU country colleagues

What You'll Bring

Education: A strong scientific/medical background — Ph.D., M.D., PharmD, MSc, or BSc in a relevant discipline.

Experience: Extensive experience in regulatory affairs, with proven success delivering global/EU regulatory strategies.

Prior experience in immunology and/or cardiovascular therapeutic areas (industry, health authority, or drug development) is preferred.

A track record of successful Health Authority negotiations, including with the EMA.

Experience leading cross-functional matrix teams in a complex, matrixed environment.

Excellent written and verbal communication skills — you make the complex clear.

Key Competencies

• Deep understanding of EU regulatory principles and procedures
• Ability to integrate scientific, regulatory, and business thinking into practical, executable strategies
• Resilient and decisive under pressure — you're comfortable navigating risk and driving resolution
• A collaborative team player who works seamlessly across organisational, functional, and geographic boundaries

Travel required as appropriate.

Ready to lead regulatory strategy that matters?

#LI-Hybrid We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident – Employer A UK Government scheme Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1607678 : Director, Regulatory Strategy Lead Europe Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.