Global Regulatory Documentation Lead

Bristol Myers Squibb EU Policy; Princeton (NJ); On-site; USD 171,000 - 207,000; Full time

Job summary

Bristol Myers Squibb in Princeton, NJ, seeks an Associate Director, Global Scientific and Regulatory Documentation, Content Strategy, to coordinate and author complex regulatory documents for global submissions. The role spans immunology and cardiovascular assets, driving document strategy, timelines, and cross-functional collaboration to ensure compliant, high-quality submissions.

The ideal candidate will bring expert regulatory writing skills, experience with registrational documents, and a

Qualifications

• Regulatory documentation experience for registrational submissions.
• Ability to analyze complex data from multiple scientific disciplines.
• Understanding global drug development documentation requirements.

Responsibilities

• Coordinate and author regulatory documents for submissions worldwide.
• Lead content strategy and maintain document prototypes and shells.
• Manage timelines and quality across cross-functional teams.
• Ensure compliance with document standards and regulatory requirements.
• Review documents for consistency within assets and TA.

Skills

Regulatory writing

CTD / registration submissions

Data interpretation across disciplines

Timeline management

Cross-functional collaboration

Document publishing knowledge

Education

PharmD/PhD/MD or Master's/Bachelor's in relevant science

Tools

Document management system

Job description

Bristol Myers Squibb in Princeton, NJ, seeks an Associate Director, Global Scientific and Regulatory Documentation, Content Strategy, to coordinate and author complex regulatory documents for global submissions. The role spans immunology and cardiovascular assets, driving document strategy, timelines, and cross-functional collaboration to ensure compliant, high-quality submissions.

The ideal candidate will bring expert regulatory writing skills, experience with registrational documents, and a