Global Regulatory CMC Lead for Cell Therapy

Bristol Myers Squibb; Princeton (NJ); On-site; USD 164,020 - 198,759; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Job summary

Bristol Myers Squibb’s Global Regulatory Sciences - CMC team seeks an Associate Director to lead content development and review of CMC submissions across global markets. You will guide manufacturing change controls, support HA submissions, and coordinate with GPS/CTDO teams to ensure regulatory success.

In this role, you will manage complex projects, provide strategic input on regulatory expectations, and interact with health authorities as part of cross-functional teams.

Qualifications

• Minimum BA/BS Degree.
• 8+ years Pharmaceutical industry experience with CMC regulatory strategy experience preferred.
• Knowledge of CMC regulatory requirements for advanced therapies, small molecules, biologics, and cell therapy.
• Experience leading regulatory strategies in coordination with clinical plans and marketing objectives.
• Strong project management, communication, and cross-functional collaboration skills.

Responsibilities

• Represent regulatory CMC on matrix teams for development and post-marketing projects.
• Provide strategic guidance on regulatory requirements for marketing and clinical trial applications.
• Manage multiple complex projects and prioritize effectively.
• Interface with Health Authorities for CMC submissions and related issues.
• Prepare and manage global CMC submissions across markets.
• Maintain regulatory compliance data entry and keep team leaders updated.

Skills

Regulatory strategy

Project management

Cross-functional collaboration

Communication skills

Team leadership

Problem solving

Attention to detail

Education

BA/BS Degree

Job description

Bristol Myers Squibb’s Global Regulatory Sciences - CMC team seeks an Associate Director to lead content development and review of CMC submissions across global markets. You will guide manufacturing change controls, support HA submissions, and coordinate with GPS/CTDO teams to ensure regulatory success.

In this role, you will manage complex projects, provide strategic input on regulatory expectations, and interact with health authorities as part of cross-functional teams.