Associate Director, Global Regulatory Sciences EU & International

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: Director Global Regulatory Sciences EU & International

• Own and drive European and International regulatory strategy execution across the product lifecycle (from early development through post-approval) providing strategic direction and regular updates to countries to ensure registration success lifecycle management delivery and launch readiness.
• Lead integration of European and International regulatory requirements into global development and lifecycle strategies partnering closely with the Global Regulatory Team (GRT) and Country Regulatory Managers (CRMs).
• Provide timely project updates to European and International countries to support execution of agreed registration strategies and ensure launch readiness.
• Define and lead in partnership with the Global Regulatory Team and Country Regulatory Managers (CRMs) the Regulatory European and International submission strategies and Health Authority engagement plans ensuring alignment with global objectives and regional needs.
• Accountable for defining EU registration scenarios procedural pathways timelines and risk-mitigation strategies to optimize product value in alignment with the GRL.
• Own holistic the International submission plan and procedural strategies addressing country-specific requirements bridging approaches ethnic sensitivity and sourcing considerations.
• Lead and represent regulatory positions in key health authority interactions; ensure consistent high-quality messaging and approve responses to HA queries across regions/countries.
• Accountable for development and implementation of target labelling strategies in alignment with global reference labelling.
• Provide strategic regulatory leadership and decision-making input to all development and lifecycle management documents (e.g. CTAs variations renewals post-approval commitments and labelling updates paediatric/orphan applications protocols) ensuring submissions and responses are accurate timely and compliant.
• Lead cross-functional rapid response teams for EU CTA queries and protocol amendments ensuring timely compliant and high-quality HA responses.
• Serve as the single point of accountability for European and International regulatory topics providing clear guidance escalation and decision support to the program team and countries.
• Lead EU health authority engagement and oversee International HA engagement aligned with the overall registration strategy.
• Oversee and approve preparation of documentation for EMA and EU national authority interactions including scientific advice pre-submission meetings.
• Provide regulatory intelligence and strategic advice monitor competitor and policy developments and lead or contribute to regulatory policy initiatives.
• Build and lead regulatory teams or networks to share learning.
• Ensure sustained regulatory compliance across the product lifecycle including governance/oversight of company core data sheet (CCDS)/reference label implementation and ongoing lifecycle maintenance
• Depending on program needs and experience may serve as Global Regulatory Lead (GRL) for an assigned program with overall accountability for the global regulatory strategy and delivery across the full product lifecycle. The GRL role encompasses: setting the global regulatory direction and key positions; leading global health authority engagement strategy; aligning regions and functions on submission/labelling/lifecycle plans; overseeing global dossiers and responses; driving risk assessment and mitigation; and ensuring inspection readiness and sustained global regulatory compliance.

Qualifications & Experience

Strategic Ownership

• Deep understanding of pharmaceutical product development and EU/International regulatory frameworks with demonstrated impact on company development strategy regulatory outcomes and business decisions.
• Strong grasp of legal regulatory and business implications of EU/International regulatory procedures enabling informed riskbenefit decisionmaking and strategic recommendations.

Leadership & DecisionMaking

• Proven ability to integrate regulatory scientific/medical and business perspectives into coherent strategies and translate them into actionable operational plans.
• Demonstrated accountability for issue resolution and decisionmaking in complex ambiguous or adverse regulatory situations including crisis management scenarios.

External Engagement & Influence

• Significant experience leading or independently conducting negotiations with regulatory authorities establishing credibility trust and influence with Health Authorities and senior internal stakeholders.
• Recognized capability to represent GRS positions externally and internally ensuring consistent highquality regulatory messaging.

People & Network Leadership

• Demonstrated success in building mentoring and sustaining effective regulatory teams or networks fostering collaboration across functions and geographies.
• Ability to navigate complex crossfunctional dynamics and lead through influence to achieve shared regulatory and business objectives.

At least 5 years of relevant regulatory experience in EU and/or International and/or Global regulatory position

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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