Director, CMC Regulatory Strategy for Cell Therapy

Bristol Myers Squibb; Princeton (NJ); On-site; USD 220,000 - 260,000; Full time

Job summary

Bristol Myers Squibb seeks a GRS-CMC Director to oversee multiple development and lifecycle management projects, guiding regulatory strategy in CMC to support global filings.

You will lead cross-functional teams, mentor staff, and represent BMS in Health Authority meetings while ensuring timely, compliant submissions.

This role is based in Princeton, NJ, offering a mission-driven culture with growth opportunities and comprehensive benefits.

Qualifications

• Minimum BA/BS Degree.
• At least 8+ years regulatory CMC experience.
• Experience with global regulatory guidelines.

Responsibilities

• Develop and communicate strategic direction based on global regulatory guidelines and experience.
• Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness.
• Review submissions from CMC Leads for clarity of both strategic and technical content.
• Utilize electronic systems for dossier creation, review, and tracking.
• Manage and actively support growth and development of direct reports.
• Actively participates in leadership or department meetings.
• Anticipate and communicate possible regulatory paradigm shifts.
• Participate in product fact finding meetings and/or R&D forums representing GRS-CMC.
• Support the preparation of CMC policies and procedures.
• Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes.

Skills

CMC regulatory

Regulatory strategy

Cross-functional leadership

Health authority engagement

Project management

Education

BA/BS Degree

Job description

Bristol Myers Squibb seeks a GRS-CMC Director to oversee multiple development and lifecycle management projects, guiding regulatory strategy in CMC to support global filings.

You will lead cross-functional teams, mentor staff, and represent BMS in Health Authority meetings while ensuring timely, compliant submissions.

This role is based in Princeton, NJ, offering a mission-driven culture with growth opportunities and comprehensive benefits.