Senior Regulatory Director - Heme/Onc (Global Strategy)

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

Benefits offered by this job

Health coverage

401(k) plan

Paid time off

Employee assistance program

Wellbeing programs

Job summary

Bristol Myers Squibb seeks an Associate Director in Regulatory Affairs to spearhead global strategy and filings for Heme/Onc products. You will drive IND/NDA submissions, coordinate with clinical and commercial teams, and ensure compliance with HA timelines.

The role requires leadership in cross-functional teams, extensive FDA experience, and a strong regulatory science background to enable timely development and life-cycle planning.

Qualifications

• PhD, MD, PharmD, BS or MS in regulatory science or related field.
• Strong experience leading FDA submissions and global regulatory strategies.
• Proven ability to coordinate cross-functional teams on regulatory plans.

Responsibilities

• Develop global regulatory strategy across development and life cycle.
• Lead regulatory dossier submissions (IND, NDA, BLA) with quality controls.
• Collaborate with cross-functional groups to define submission contributions.
• Participate in/regional Regulatory Sub-team oversight for products.
• Draft/Review regulatory documents (INDs, briefing books, ODD).
• Engage in regulatory interactions with FDA; assist with global plans.

Skills

Regulatory affairs

FDA submissions

Cross-functional leadership

Project management

Global regulatory strategy

IND/NDA submissions

Education

Regulatory science degree

Job description

Bristol Myers Squibb seeks an Associate Director in Regulatory Affairs to spearhead global strategy and filings for Heme/Onc products. You will drive IND/NDA submissions, coordinate with clinical and commercial teams, and ensure compliance with HA timelines.

The role requires leadership in cross-functional teams, extensive FDA experience, and a strong regulatory science background to enable timely development and life-cycle planning.