Regulatory CMC Director, Cell Therapy

Bristol-Myers Squibb Co; Alabama; Hybrid; USD 210,000 - 270,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Volunteer days

Global Shutdown

Job summary

Bristol Myers Squibb is seeking a GRS-CMC Director to lead strategic CMC regulatory activities across development and lifecycle. You will collaborate with cross-functional teams and health authorities to drive timely, compliant submissions and robust regulatory strategies.

The role emphasizes leadership of direct reports, alignment with clinical plans, and proactive engagement with external regulatory bodies to advance products in cell therapy and related modalities.

Qualifications

• Minimum BA/BS Degree.
• 10+ years pharmaceutical or related experience with regulatory CMC.
• Experience leading cross-functional teams and interactions with health authorities.

Responsibilities

• Develop and communicate regulatory strategy for CMC across development and lifecycle.
• Oversee preparation of CMC submissions for global regulatory bodies.
• Review submissions for strategic and technical content clarity and timeliness.
• Lead teams and mentor direct reports to achieve regulatory milestones.
• Represent GRS-CMC in cross-functional and external Regulatory engagements.

Skills

CMC regulatory knowledge

Regulatory strategy development

Leadership

Cross-functional collaboration

Health Authority communications

Education

Bachelor's degree

Tools

Regulatory Information Management system

Job description

Bristol Myers Squibb is seeking a GRS-CMC Director to lead strategic CMC regulatory activities across development and lifecycle. You will collaborate with cross-functional teams and health authorities to drive timely, compliant submissions and robust regulatory strategies.

The role emphasizes leadership of direct reports, alignment with clinical plans, and proactive engagement with external regulatory bodies to advance products in cell therapy and related modalities.