Director of Global Regulatory CMC & Health Authority Strategy

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

Benefits offered by this job

Incentive cash

Stock opportunities

Job summary

Bristol Myers Squibb is seeking a GRS-CMC Director in Princeton, NJ, to oversee multiple development and lifecycle projects. You will lead cross-functional teams, represent the company in Health Authority meetings, and drive regulatory strategies based on global guidelines and prior regulatory experience.

The role includes developing strategic direction, ensuring timely submissions, and maintaining compliance across CMC activities.

Qualifications

• Minimum BA/BS Degree; 8+ years regulatory CMC experience.
• Experience leading cross-functional teams and coordinating with health authorities.
• Strong understanding of global regulatory guidelines for drug development and approval.

Responsibilities

• Develop and communicate regulatory strategy for CMC in line with global guidelines.
• Oversee preparation and review of CMC submissions for quality and timeliness.
• Coordinate with CMC Leads on dossier creation, review, and tracking systems.
• Lead and develop direct reports; participate in leadership meetings.
• Anticipate regulatory paradigm shifts and communicate impacts to teams.
• Represent GRS-CMC in health authority discussions and cross-functional forums.
• Support formulation of CMC policies, procedures, and compliance monitoring.

Skills

Regulatory CMC leadership

Cross-functional leadership

Regulatory strategy

Education

BA/BS Degree

Job description

Bristol Myers Squibb is seeking a GRS-CMC Director in Princeton, NJ, to oversee multiple development and lifecycle projects. You will lead cross-functional teams, represent the company in Health Authority meetings, and drive regulatory strategies based on global guidelines and prior regulatory experience.

The role includes developing strategic direction, ensuring timely submissions, and maintaining compliance across CMC activities.