Global Regulatory Strategy Director

VetJobs; Princeton (NJ); On-site; USD 210,000 - 290,000; Full time

Job summary

Bristol Myers Squibb in Princeton, NJ, seeks an experienced Regulatory Leader to design and execute global regulatory strategies for development projects. You will coordinate with Clinical, QA and Manufacturing teams, manage HA interactions, and translate strategy into actionable submission plans.

The role emphasizes risk assessment, strategic input on study plans, and leadership of cross-functional teams, with on-site collaboration in New Jersey.

Qualifications

• 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.

Responsibilities

• Develop and lead Global and US Regulatory activities for development teams, leveraging external resources for operations and internal resources for strategy.
• Provide strategic regulatory input on target product profile, CCDS, and country-specific label.
• Create asset-specific HA interaction strategies and lead regulatory interactions globally.
• Formulate US regulatory strategy and filings and translate into operational plans with external vendors.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Communication skills

Education

High School/GED

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

Tools

Regulatory databases

Job description

Bristol Myers Squibb in Princeton, NJ, seeks an experienced Regulatory Leader to design and execute global regulatory strategies for development projects. You will coordinate with Clinical, QA and Manufacturing teams, manage HA interactions, and translate strategy into actionable submission plans.

The role emphasizes risk assessment, strategic input on study plans, and leadership of cross-functional teams, with on-site collaboration in New Jersey.