Director, Regulatory Strategy Lead Europe

Bristol Myers Squibb; Denham; Hybrid; GBP 120,000 - 160,000; Full time

Job summary

Bristol Myers Squibb is seeking a seasoned European Regulatory Strategy Lead to champion its Immunology & Cardiovascular portfolio from development through registration and lifecycle management.

You will act as regulatory compass for Development Teams with EU focus, leading plans and negotiations with EMA. Strong scientific background and stakeholder influence are essential.

Qualifications

• PhD/MD/PharmD/MSc/BSc in a relevant discipline.
• Extensive experience in regulatory affairs with global/EU regulatory strategies.
• Experience leading EU regulatory submissions and negotiations with health authorities, especially EMA.

Responsibilities

• Define and drive EU regulatory strategy across development, registration, and lifecycle management.
• Lead negotiations with the EMA and other health authorities, translating strategy into outcomes.
• Build integrated submission plans and translate into actionable 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.
• Monitor evolving European and international regulatory trends and position the company ahead of the curve.
• Build and nurture strong relationships with Health Authorities, alliance partners, and EU country colleagues.

Skills

Regulatory strategy

EU regulatory affairs

Cross-functional leadership

EMA negotiations

Scientific communication

Education

PhD/MD/PharmD/MSc/BSc in relevant discipline

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.

What You’ll Do

Role

As the European Regulatory Lead (ERL), you’ll be the regulatory compass for your assigned Development Team(s), with the EU as your primary focus. In this role, you and the team will:

• 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.

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.

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Data Protection

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