Associate Director, Global Regulatory CMC (Cell Therapy)

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

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and 401(k)

Job summary

Bristol Myers Squibb in Madison, NJ seeks a GRS-CMC Associate Director to lead regulatory content development for CMC submissions across global markets. You will collaborate with Global Regulatory Sciences and GPS/CTDO, providing strategic input and guiding change management to support product lifecycle goals.

The role focuses on compiling and reviewing quality modules for submissions, assessing manufacturing changes, and ensuring compliance with health authority expectations while supporting

Qualifications

• BA/BS Degree minimum.
• 8+ years pharmaceutical industry experience with 5+ years in CMC regulatory strategy.
• Knowledge of CMC regulatory requirements for advanced therapies, small molecules, biologics or cell therapy.
• Experience leading teams and coordinating global activities.
• Strong written and verbal communication; ability to influence outcomes.

Responsibilities

• Represent regulatory CMC on matrix teams for diverse products and projects.
• Provide strategic guidance on regulatory requirements for marketing and clinical trial applications.
• Lead and prioritize multiple complex projects.
• Interface with Health Authorities for CMC submissions with supervisor guidance.
• Prepare and manage CMC submissions for global markets; ensure timely, thorough documentation.

Skills

CMC regulatory strategy

Regulatory submissions

Project management

Team leadership

Regulatory guidance

Education

BA/BS Degree

Tools

Regulatory Information Management systems

Job description

Bristol Myers Squibb in Madison, NJ seeks a GRS-CMC Associate Director to lead regulatory content development for CMC submissions across global markets. You will collaborate with Global Regulatory Sciences and GPS/CTDO, providing strategic input and guiding change management to support product lifecycle goals.

The role focuses on compiling and reviewing quality modules for submissions, assessing manufacturing changes, and ensuring compliance with health authority expectations while supporting