Director, CMC Regulatory Strategy (Cell Therapy)

Bristol Myers Squibb; Alabama; On-site; USD 247,000 - 299,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) and financial protection

Job summary

Bristol Myers Squibb seeks a Director of Regulatory CMC to lead strategic direction for CMC regulatory activities across development and life-cycle management for cell therapy programs. The role involves coordinating with health authorities, guiding cross-functional teams, and ensuring timely, compliant submissions.

The position requires extensive experience in regulatory CMC, including interaction with global authorities, and leadership of multiple projects and teams within a matrix

Qualifications

• Minimum BA/BS Degree.
• Minimum 10 years pharmaceutical or related experience; 8+ years regulatory CMC experience preferred.

Responsibilities

• Develop and communicate strategic direction based on global regulatory guidelines.
• Prepare or oversee CMC submissions ensuring thoroughness and timeliness.
• Review submissions for clarity of content.
• Utilize electronic systems for dossier creation, review, and tracking.
• Manage and support the development of direct reports.
• Lead cross-functional teams and participate in governance meetings.
• Engage with health authorities to communicate regulatory strategy.
• Contribute to development of CMC policies and procedures.

Skills

CMC regulatory

Regulatory strategy

Leadership

Cross-functional

Communication

Education

BA/BS Degree

Tools

Electronic systems

Job description

Bristol Myers Squibb seeks a Director of Regulatory CMC to lead strategic direction for CMC regulatory activities across development and life-cycle management for cell therapy programs. The role involves coordinating with health authorities, guiding cross-functional teams, and ensuring timely, compliant submissions.

The position requires extensive experience in regulatory CMC, including interaction with global authorities, and leadership of multiple projects and teams within a matrix