Temporary - Associate Manager, Regulatory Project Management
Core
Lead strategic planning and execution of regulatory milestones from IND Project Approval to post-marketing for assigned therapeutic areas.
Role type
Associate Manager, Regulatory Project Management
Builds
Regulatory submission timelines and responsibility matrices for INDs, CTAs, BLAs, sBLAs, MAAs, and variations
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Regulatory agency regulations knowledge (FDA, EMA, ICH), eCTD, Microsoft Project, cross-functional coordination, program timeline management
Preferred skills
Project management, electronic document management systems (SharePoint)
Technologies
Microsoft Project, MS Office, Adobe Acrobat, SharePoint
Responsibilities
Facilitate Global Regulatory Sub-team meetings, conduct working group meetings to track submission progress, create submission timelines and responsibility matrices, maintain accurate program timelines, provide guidance to resolve regulatory-related issues, oversee therapeutic area regulatory milestones
Seniority
Associate Manager, hands-on IC