Director, Regulatory Strategy Lead Europe

Director, Regulatory Strategy Lead Europe

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

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.

• Ready to lead regulatory strategy that matters?