Director, Regulatory Strategist

Bristol Myers Squibb

Director of Regulatory Strategy overseeing global and US regulatory activities at BMS. Collaborating with cross-functional teams to deliver effective registration strategies and resolve regulatory issues.

Posted 7/21/2026full-timePrinceton Pike • Massachusetts, New Jersey • 🇺🇸 United StatesLead💰 $240,940 - $291,964 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and leading global and US regulatory strategies, with a strong focus on effective communication and collaboration across cross-functional teams. Proven ability to navigate complex regulatory environments and deliver successful registration outcomes.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Regulatory Strategy DevelopmentCross-Functional Team LeadershipRegulatory Document ApprovalHA Interaction Strategy

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyRegulatory FilingsRisk Mitigation StrategiesScientific CommunicationRegulatory Dossier Compilation

Soft Skills

Effective CommunicationInfluencing SkillsProblem-Solving

Certifications & Qualifications

Ph.D.M.D.PharmDMSBS

Industry Keywords

Regulatory ComplianceClinical PlansMarketing ObjectivesGlobal Health AuthoritiesDevelopment Plans

About the role

Key responsibilities & impact

Develop and lead Global and US Regulatory activities for a Development Team (s).
Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans.
Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed.
Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders.
Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources.
Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies.
Provide strategic regulatory input to key development documents and study reports.
Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally.
Formulate US regulatory strategy and filings.
Approval of regulatory documents.
Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines.

Requirements

What you’ll need

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
Significant experience in regulatory affairs (e.g. > 4-7 years)
Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
Experience leading cross functional matrix teams
Demonstrated ability to break down complex, scientific issue and communicating regulatory implications
Proven success in negotiating regulatory objectives with HA.

Benefits

Comp & perks

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.