Global Regulatory Strategy Director - Oncology

Bristol Myers Squibb; Princeton (NJ); On-site; USD 173,000 - 210,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

401(k) plan

Paid Time Off

Job summary

Bristol Myers Squibb is seeking an Associate Director, Global Regulatory Strategy, Hematology/Oncology, to lead global regulatory strategy from development through lifecycle management. You will oversee submissions to global authorities and FDA, coordinate cross-functional teams, and draft critical regulatory documents to support INDs, NDAs and labeling.

Travel may be required. The role requires strong leadership, deep regulatory expertise, and the ability to drive strategic decisions in a

Qualifications

• PhD/MD/Pharm.D./BS or MS in regulatory science is required.
• 4–8 years of pharmaceutical industry experience, with 3–5 years in regulatory affairs.
• Thorough knowledge of the drug development process, IND and NDA submissions.

Responsibilities

• Develop global regulatory strategy for development and lifecycle management.
• Lead regulatory submissions to global agencies and FDA (IND, BLA, NDA and supplements).
• Collaborate with cross-functional teams to contribute to submissions and responses.
• Draft regulatory documents (INDs, briefing books, designation requests), review core documents.
• Support rapid response to CTA queries on protocol amendments within HA deadlines.
• Lead or participate in FDA interactions as needed.
• Develop global submission and Health Authority interaction plans.

Skills

Regulatory strategy

Cross-functional collaboration

Team leadership

Project management

Attention to detail

Communication

Travel readiness

Education

PhD/MD/Pharm.D./BS/MS in regulatory science

Job description

Bristol Myers Squibb is seeking an Associate Director, Global Regulatory Strategy, Hematology/Oncology, to lead global regulatory strategy from development through lifecycle management. You will oversee submissions to global authorities and FDA, coordinate cross-functional teams, and draft critical regulatory documents to support INDs, NDAs and labeling.

Travel may be required. The role requires strong leadership, deep regulatory expertise, and the ability to drive strategic decisions in a