Manager, Regulatory Affairs Project Management

$134.51k - $162.99k

Bristol Myers Squibb

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a regulatory project management professional to oversee planning and execution of submissions across clinical and nonclinical oncology programs. The role coordinates cross-functional timelines, deliverables, and stakeholder communication to ensure timely, high-quality regulatory filings.

Responsibilities

Lead planning, coordination, and execution of regulatory submissions and activities (INDs, CTAs, NDAs, MAAs, IMPDs, briefing packages)
Develop and proactively manage detailed regulatory project timelines, schedules, and identify risks with mitigation strategies
Serve as primary regulatory project management contact; communicate status and progress to stakeholders and leadership
Facilitate cross-functional meetings and ensure clarity of roles, responsibilities, and deliverables across programs
Prepare submission trackers, project dashboards, and provide regular status updates to regulatory leadership

Requirements

Bachelor's degree or higher in scientific or related discipline
Minimum 5 years regulatory affairs, project management, life sciences, or healthcare experience
Hands-on experience supporting or leading major global regulatory submissions; NDA filing preferred
Experience supporting oncology development programs
Proficiency with project timeline software (MS Project, Smartsheet) and MS Office suite
Working knowledge of global regulations, guidances, and regulatory standards
Strong cross-functional relationship building and communication abilities

Compensation: $134,505 - $162,988 base

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Vacancy posted 7 days ago

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