Global CMC Regulatory Strategy Lead

Bristol-Myers Squibb Co; Princeton (NJ); On-site; USD 164,000 - 199,000; Full time

Benefits offered by this job

Wellbeing support

Retirement benefits

Insurance (medical, dental, vision, 6/

Flexible Time Off

11 paid holidays

Paid vacation

Job summary

Bristol Myers Squibb is seeking an Associate Director in Global Regulatory Sciences - CMC to lead regulatory strategies across global programs, including development and post-approval activities. The role emphasizes collaboration with GPS/CTDO and senior teams to navigate CMC-related regulatory challenges.

The position requires extensive experience in small molecule/biotech/cell therapy regulatory activities, strong project management, and the ability to influence cross-functional teams to

Qualifications

• BA/BS degree required with 8+ years in pharmaceutical regulatory affairs.
• 5+ years of CMC regulatory strategy experience.
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules.
• Experience leading teams and coordinating global regulatory activities.

Responsibilities

• Represent regulatory CMC on matrix teams for small molecules, biologics, and devices.
• Provide strategic guidance on marketing and clinical trial applications.
• Prepare and manage CMC submissions for global markets.
• Interface with health authorities on CMC submissions and issues.

Skills

CMC regulatory strategy

Regulatory affairs

Cross-functional collaboration

Project management

Regulatory submissions

Electronic systems

Education

BA/BS Degree

Tools

Electronic systems

Job description

Bristol Myers Squibb is seeking an Associate Director in Global Regulatory Sciences - CMC to lead regulatory strategies across global programs, including development and post-approval activities. The role emphasizes collaboration with GPS/CTDO and senior teams to navigate CMC-related regulatory challenges.

The position requires extensive experience in small molecule/biotech/cell therapy regulatory activities, strong project management, and the ability to influence cross-functional teams to