Mirum develops patient-inspired therapies for rare disease, advancing medicines where unmet need is greatest. Mirum is relentlessly rare. Learn more. Backed by NEA.
About the role
The Director, Regulatory Project Management provides strategic leadership and oversight for the planning and execution for Regulatory Medical Writing (RMW) Department deliverables, including, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent). An advanced degree is desirable
- 10+ years in the pharmaceutical industry with a deep understanding of drug development
- Prior project management experience with NDA/MAA/Lifecycle submissions and review is required
- Expert in project management with advanced expertise using related software and tools (e.g. MS Project, Sharepoint, Veeva, etc)
- Demonstrated experience in leading decision-making within cross-functional teams
- Excellent organizational and communication skills, both written and verbal
More about this role
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
The Director, Regulatory Project Management provides strategic leadership and oversight for the planning and execution for Regulatory Medical Writing (RMW) Department deliverables, including, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs. This position will contribute to regulatory submission strategy, working in close collaboration with the RMW team, Global Regulatory Lead (GRL), as well as cross-functional teams to identify submission risks and opportunities, define regulatory deliverables, and build timelines/dashboards to support regulatory filings through licensure and beyond.
The Director also serves as a...
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