Global Regulatory CMC Lead

Regulatory Jobs; Princeton (NJ); On-site; USD 164,000 - 199,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

11 paid company holidays

Job summary

Bristol Myers Squibb is seeking an Associate Director, Global Regulatory Sciences - CMC to lead regulatory CMC strategies across global markets. You will collaborate with development, clinical, and manufacturing teams to shape regulatory pathways and submissions, ensuring compliance and timely approvals.

The role requires extensive experience in CMC regulatory affairs, strong leadership, and the ability to influence across functions.

Qualifications

• BA/BS degree required.
• 8+ years pharmaceutical industry experience with small molecules, biotech or cell therapy.
• Knowledge of CMC regulatory requirements for development and post-approval.
• Experience leading regulatory strategy on projects with cross-functional teams.

Responsibilities

• Represent regulatory CMC on matrix teams for development and lifecycle projects.
• Provide strategic guidance on regulatory requirements for marketing and clinical trial applications.
• Manage multiple complex projects and prioritize work.
• Interface with Health Authorities on CMC submissions and issues.
• Prepare and manage global CMC filings with timely updates to strategy documents.
• Identify risks and suggest mitigation strategies to ensure regulatory success.

Skills

Regulatory strategy (CMC)

Cross-functional collaboration

Project management

Regulatory communications

Education

BA/BS Degree

Tools

Regulatory Information Management (RIM) systems

Job description

Bristol Myers Squibb is seeking an Associate Director, Global Regulatory Sciences - CMC to lead regulatory CMC strategies across global markets. You will collaborate with development, clinical, and manufacturing teams to shape regulatory pathways and submissions, ensuring compliance and timely approvals.

The role requires extensive experience in CMC regulatory affairs, strong leadership, and the ability to influence across functions.