Associate Director, Global Regulatory Sciences – CMC

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 164,020 - 198,759; Full time

Job summary

Bristol-Myers Squibb is seeking an Associate Director, Global Regulatory Sciences - CMC in New Jersey. You will lead regulatory CMC strategies across small molecules, biologics, and cell therapy, coordinating with GPS/CTDO teams to ensure alignment with clinical and marketing objectives.

Responsibilities include shaping submissions and interacting with health authorities. Ideal candidates bring extensive CMC regulatory expertise, strong leadership, and a proven ability to drive complex projects

Qualifications

• Minimum BA/BS Degree required.
• 8+ years pharmaceutical industry experience, including multi-disciplinary experience.
• 5+ years CMC regulatory strategy experience and ability to lead teams.

Responsibilities

• Represent regulatory CMC on project teams and lead regulatory strategy.
• Provide strategic input to development and GO teams for regulatory submissions and lifecycle changes.
• Prepare and manage global CMC submissions ensuring thoroughness and timeliness.

Skills

Regulatory strategy

Project leadership

Cross-functional

Regulatory submissions

Communication

Problem solving

Education

BA/BS Degree

Tools

RIM systems

Job description

Bristol-Myers Squibb is seeking an Associate Director, Global Regulatory Sciences - CMC in New Jersey. You will lead regulatory CMC strategies across small molecules, biologics, and cell therapy, coordinating with GPS/CTDO teams to ensure alignment with clinical and marketing objectives.

Responsibilities include shaping submissions and interacting with health authorities. Ideal candidates bring extensive CMC regulatory expertise, strong leadership, and a proven ability to drive complex projects