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Position Summary:
- Manage regulatory filing subteams and subteam operations.
- Develop and maintain detailed regulatory timelines.
- Resolve submission execution issues and track functional submission milestones.
Responsibilities:
- Partner with Regulatory leads for regulatory filing activities.
- Develop program- and portfolio-level reports and dashboards.
- Facilitate regulatory filing team meetings.
Requirements:
- Bachelor’s degree with >8-10 years of regulatory project management experience.
- Working knowledge of global regulatory agency regulations and guidelines.
- Exceptional project management and organizational skills required.
Ultragenyx
Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.