We are currently seeking an experienced Regulatory Project Manager (PM) to support our client with PM support with respect to MAA and NDA submissions for small molecule products. The project is beginning the planning for phase III data read out in Q3 along with having had an NDA kick off meeting where the plan is currently being built out with intent to kick off additional filing sub teams that would be driving this work. The project will require a skilled Project Manager with NDA submission filling experience for small molecule products.
Responsibilities include (but not limited to):
Partner with global regulatory lead and filing lead for planning, strategy, and overall cross-functional collaboration with other departments such as CMC, Clinical, Tox, ClinPharm, etc.
Facilitate with contingency planning & risk mitigation strategies
Manage dashboards/dashboard reporting for submission & project status updates
Meeting management, driving & managing critical deadlines, critical path assessment, and risk management
Engage closely with project lead & additional stakeholders to provide content, status updates, and assist with overall submission activities
Minimum 5-10 years of Project Management expertise
Previous experience with at least 2-3 regulatory NDA/MAA submissions
Strong cross-functional collaboration
Excellent communication and organizational skills
Bonus/Nice to have:
Bachelor’s degree preferred
Remote in CA: Regulatory Project Manager (232890)