Head of Regulatory CMC, Cell Therapy

Bristol Myers Squibb; Lawrence Township (NJ); On-site; USD 200,000 - 242,000; Full time

Benefits offered by this job

Flexible Time Off

Comprehensive benefits

Holidays & shutdown

Job summary

Bristol Myers Squibb is seeking a Director, Regulatory CMC - Cell Therapy to oversee multiple development and lifecycle management projects. You will represent GRS-CMC on cross-functional teams and health authority discussions, shaping regulatory strategy for cell therapy programs.

The role requires deep CMC regulatory expertise, leadership and a track record in global regulatory engagement. Travel up to 5% may be required, with comprehensive benefits and a supportive, inclusive culture.

Qualifications

• BA/BS degree minimum.
• 10+ years pharmaceutical or related experience, 8+ years regulatory CMC.
• Experience with advanced therapies and cell therapy developments.

Responsibilities

• Develop and communicate strategic regulatory direction for CMC.
• Prepare or oversee CMC submissions ensuring thoroughness and timeliness.
• Review CMC submissions for clarity and technical content.
• Utilize electronic systems for dossier creation, review, and tracking.
• Support growth and development of direct reports.

Skills

CMC regulatory knowledge

Drug development knowledge

Cross-functional leadership

Stakeholder communication

Regulatory strategy

Education

BA/BS Degree

Tools

Regulatory Information Management (RIM) system

Job description

Bristol Myers Squibb is seeking a Director, Regulatory CMC - Cell Therapy to oversee multiple development and lifecycle management projects. You will represent GRS-CMC on cross-functional teams and health authority discussions, shaping regulatory strategy for cell therapy programs.

The role requires deep CMC regulatory expertise, leadership and a track record in global regulatory engagement. Travel up to 5% may be required, with comprehensive benefits and a supportive, inclusive culture.