Regulatory CMC Director, Cell Therapy Leader

Bristol-Myers Squibb; Madison (NJ); On-site; USD 199,950 - 242,297; Full time

Benefits offered by this job

Health Coverage

401(k) plan

Flexible time off

Job summary

Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development and lifecycle management projects, ensuring regulatory compliance and strategic direction in alignment with global guidelines.

The ideal candidate will have significant experience in regulatory CMC and strong leadership skills, enabling them to effectively manage cross-functional teams and navigate complex regulatory environments. The position offers competitive compensation and comprehensive benefits.

Qualifications

• Minimum 10 years pharmaceutical experience, with 8+ years in regulatory CMC.
• Experience with advanced therapies and cell therapy development.
• Demonstrated ability to lead cross-functional teams.

Responsibilities

• Develop and communicate strategic direction based on global regulatory guidelines.
• Oversee preparation of CMC submissions ensuring clarity and timeliness.
• Manage relationships with diverse teams and promote regulatory compliance.

Skills

CMC regulatory requirements

Pharmaceutical development

Interpersonal skills

Negotiation and influence

Education

BA/BS Degree

Tools

Regulatory Information Management system

Job description

Bristol-Myers Squibb is seeking a Director, Regulatory CMC for Cell Therapy in Madison, NJ. In this pivotal role, you will oversee multiple development and lifecycle management projects, ensuring regulatory compliance and strategic direction in alignment with global guidelines.

The ideal candidate will have significant experience in regulatory CMC and strong leadership skills, enabling them to effectively manage cross-functional teams and navigate complex regulatory environments. The position offers competitive compensation and comprehensive benefits.