Global Regulatory Strategy Director

Regulatory Jobs; Princeton (NJ); Hybrid; USD 215,000 - 292,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

Financial Well-being

Job summary

Bristol Myers Squibb is seeking a senior Regulatory Lead to drive Global and US regulatory strategies for development teams. You will coordinate internal and external resources to resolve regulatory issues and lead cross-functional efforts across timelines and clinical plans.

The role requires delivering strategic regulatory input on submissions, with focus on global harmonization, care for risk mitigation, and collaboration with health authorities to ensure successful registrations.

Qualifications

• Proven success delivering global regulatory strategies aligned with clinical plans and marketing.
• Excellent communication of regulatory strategy, issues, and risks.
• Experience leading cross-functional matrix teams.
• Ability to break down complex scientific issues and explain regulatory implications.
• Proven success negotiating with health authorities.

Responsibilities

• Develop and lead Global and US Regulatory activities for multiple development teams.
• Collaborate with internal experts and external resources to address regulatory issues.
• Provide leadership to resolve critical regulatory project issues.
• Develop registration strategies and translate into operational plans with vendors.
• Formulate US regulatory strategy and global submission plans.

Skills

Regulatory strategy

Leadership

Cross-functional

HA negotiation

Education

Ph.D., M.D., PharmD, MS, or BS

Job description

Bristol Myers Squibb is seeking a senior Regulatory Lead to drive Global and US regulatory strategies for development teams. You will coordinate internal and external resources to resolve regulatory issues and lead cross-functional efforts across timelines and clinical plans.

The role requires delivering strategic regulatory input on submissions, with focus on global harmonization, care for risk mitigation, and collaboration with health authorities to ensure successful registrations.