About this opportunity
Bristol Myers Squibb lists this Associate Director Global Regulatory Sciences - Oncology opportunity in princeton, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Role: Associate Director, Global Regulatory Strategy in Hematology/Oncology
leading regulatory development and lifecycle management for oncology therapeutics.
Responsibilities
develop global and US regulatory strategies, oversee submission of INDs, BLAs, NDAs, and supplements, ensure quality and compliance in dossiers, manage cross-functional contributions, write and review regulatory documents, and lead interactions with FDA and other health authorities.
Qualifications
PhD, MD, PharmD, or equivalent; 4-8 years in pharma, with significant regulatory affairs experience and strong knowledge of IND/NDA processes.
Preferred
extensive US regulatory submission experience, team leadership skills, project management expertise, and ability to influence cross-functional teams.
High-Value
focus on oncology (hemato-oncology), lifecycle management, FDA interactions, global submission planning, and cross-functional collaboration.
Work Setup
likely hybrid or onsite, with some travel required.
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Worksite address
princeton, NJ, 08543, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.