Regulatory Intelligence & Standards Leader

Bristol Myers Squibb EU Policy; New Brunswick (NJ); On-site; USD 164,000 - 199,000; Full time

Job summary

Bristol Myers Squibb is seeking an Associate Director to lead MQSA Regulatory Intelligence and Standards in New Jersey. You will drive regulatory intelligence, governance, and inspection readiness across the enterprise and external manufacturing partners.

You will engage with Health Authorities and set strategic direction for sterility assurance, aseptic processing, and cGMP compliance, coordinating with QA, Operations, and Strategy teams to ensure global regulatory alignment.

Qualifications

• Bachelor's degree or equivalent in a relevant scientific discipline.
• Demonstrates advanced knowledge of sterility assurance, contamination control, and aseptic processing.
• Extensive experience with global Health Authorities in inspections and regulatory filings.

Responsibilities

• Lead day-to-day inspection readiness activities across the commercial manufacturing network for CCS/SA.
• Develop and maintain inspection-ready documentation packages and regulatory response materials.
• Coordinate with site quality teams to ensure defensible, science-based regulatory responses.
• Drive governance and standardization of CCS/SA across CMO/CDMO networks.
• Support enterprise regulatory intelligence, horizon scanning, and change management.
• Engage with Health Authorities and industry bodies during inspections and inquiries.

Skills

Regulatory intelligence

Compliance management

cGMP knowledge

Leadership

Education

MS in Microbiology or related field

Bachelor's degree in related scientific discipline

Job description

Bristol Myers Squibb is seeking an Associate Director to lead MQSA Regulatory Intelligence and Standards in New Jersey. You will drive regulatory intelligence, governance, and inspection readiness across the enterprise and external manufacturing partners.

You will engage with Health Authorities and set strategic direction for sterility assurance, aseptic processing, and cGMP compliance, coordinating with QA, Operations, and Strategy teams to ensure global regulatory alignment.