Director, CMC Regulatory Strategy - Cell Therapy

Bristol Myers Squibb; Brisbane (CA); On-site; USD 224,000 - 271,000; Full time

Benefits offered by this job

Wellbeing support

Retirement and financial protection

Insurance offerings (medical, dental,…

Flexible work models

Job summary

Bristol Myers Squibb is seeking a GRS-CMC Director to oversee management of multiple development and life-cycle projects, represent the group on cross-functional teams, and engage with Health Authorities.

The role emphasizes strategic direction based on global guidelines, preparation of CMC submissions, and leadership of direct reports, with up to 5% travel. Compensation reflects senior regulatory leadership in pharma.

Qualifications

• Minimum BA/BS Degree
• Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience

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 knowledge

Cross-functional leadership

Regulatory strategy

Stakeholder engagement

Project management

Education

BA/BS Degree

Tools

Regulatory submissions software

Job description

Bristol Myers Squibb is seeking a GRS-CMC Director to oversee management of multiple development and life-cycle projects, represent the group on cross-functional teams, and engage with Health Authorities.

The role emphasizes strategic direction based on global guidelines, preparation of CMC submissions, and leadership of direct reports, with up to 5% travel. Compensation reflects senior regulatory leadership in pharma.