Associate Director, Global Regulatory Strategy (Heme/Onc)

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 173,350 - 210,058; Full time

Benefits offered by this job

Health coverage

401(k) plan

Paid time off

Job summary

Bristol-Myers Squibb is looking for an Associate Director in Princeton, NJ to lead regulatory dossier submissions and develop strategies for global regulatory compliance. The ideal candidate has a strong background in regulatory affairs and significant experience with FDA submissions.

Key responsibilities include managing cross-functional teams and ensuring compliance with drug development processes. Applicants should have a PhD, MD, or equivalent, and experience in the pharmaceutical industry.

Qualifications

• 4-8 years pharmaceutical industry experience, particularly in regulatory affairs.
• Strong experience with US Regulatory submissions (INDs, NDAs).
• Ability to innovate, analyze, and solve problems with minimal supervision.

Responsibilities

• Lead regulatory dossier submissions to FDA and ensure compliance.
• Develop global regulatory strategies and submission plans.
• Manage cross-functional teams for regulatory submissions.

Skills

Regulatory submission expertise

Leadership skills

Project management

Education

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

Job description

Bristol-Myers Squibb is looking for an Associate Director in Princeton, NJ to lead regulatory dossier submissions and develop strategies for global regulatory compliance. The ideal candidate has a strong background in regulatory affairs and significant experience with FDA submissions.

Key responsibilities include managing cross-functional teams and ensuring compliance with drug development processes. Applicants should have a PhD, MD, or equivalent, and experience in the pharmaceutical industry.