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About the Role
Bristol Myers Squibb is seeking a Director, European Regulatory Strategy Lead to champion the Immunology & Cardiovascular (ICV) portfolio through the European approval landscape, from early development through registration and lifecycle management. This role influences how transformative therapies reach patients across Europe.
Responsibilities
- Define and drive EU regulatory strategy across development, registration, and lifecycle management.
- Lead negotiations with the EMA and other relevant Health Authorities.
- Build integrated submission plans and translate them into operational deliverables.
- 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 and anticipate evolving European and international regulatory trends.
- Build and nurture strong relationships with Health Authorities, alliance partners, and EU country colleagues.
Requirements
- Extensive experience in regulatory affairs, with proven success delivering global/EU regulatory strategies.
- Prior experience in immunology and/or cardiovascular therapeutic areas 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.
Skills
- 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.
- Collaborative team player.
Location
- Europe
Work Type
- Hybrid
Experience Level
- Director
Education Level
- Ph.D., M.D., PharmD, MSc, or BSc in a relevant discipline.
Benefits
- Comprehensive benefits
About the Company
- 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.
Equal Opportunity
- 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.
- Bristol Myers Squibb is Disability Confident – Employer
- BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.