Regulatory Project Manager/Senior Manager
$143,000–$175,000 year
HybridSouth San Francisco, California, United States
Job Summary
Maintain integrated plans and timelines for regulatory activities, including health authority interactions, IND amendments, and major program milestones. Partner with Medical Writing to track document development cycles, review resolutions, and readiness dates for key clinical documents. Coordinate cross-functional contributors across regulatory, clinical, technical, and external partner teams to ensure workstreams move forward with accountability. Track actions, owners, dependencies, and risks to identify bottlenecks early and prepare status updates and dashboards for the Regulatory team. Establish fit-for-purpose project management tools and templates that support timely execution of regulatory milestones as Maze advances its clinical programs toward later-stage development.
Required Qualifications
- 5+ years of project management experience in the biopharmaceutical industry
- experience supporting Regulatory Affairs
- experience supporting clinical development
- experience supporting regulatory submission activities
- Bachelor's degree in a scientific, health-related, or business discipline
Desired Qualifications
- advanced degree
- project management certification
- Working knowledge of drug development and regulatory processes
- Working knowledge of health authority interactions
- Working knowledge of IND maintenance activities
- Working knowledge of major clinical development milestones
- Demonstrated ability to build and manage project plans
- Demonstrated ability to manage timelines
- Demonstrated ability to manage trackers
- Demonstrated ability to manage dashboards
- Demonstrated ability to manage meeting agendas
- Demonstrated ability to manage status updates
- proficiency with common project management tools
- Strong organizational judgment
- attention to detail
- ability to track actions
- ability to track dependencies
- ability to track decisions
- ability to track risks
- ability to track follow-ups
- ability to work across multiple workstreams
- Excellent communication skills
- collaboration skills
- ability to work effectively in a hands-on, fast-paced biotech environment
- ability to work with internal stakeholders
- ability to work with external partners
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.