Manager, Regulatory Affairs Project Management
$134.51k - $162.99kBristol 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
Vacancy posted a month ago
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