Manager I, Global Submission Management - CMC
Core
Manage end-to-end regulatory activities including preparation and compilation of compliant US IND and marketing complex submissions for global health authorities.
Role type
Manager I, Regulatory Submission Management
Builds
Regulatory submissions (IND and Marketing) for global health authorities
Domain
Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory practices knowledge, Risk and critical path management, Project management, eCTD publishing system proficiency, RIM systems proficiency, Cross-functional alignment
Preferred skills
Science/technology degree background, AI and automation tool usage
Technologies
eCTD publishing system, Veeva RIM
Responsibilities
Collaborate with stakeholders to define eCTD submission strategies and document requirements, Drive execution of the Global Submission Plan, Track and ensure timely progress of submission components to Health Authorities, Execute submission management and publishing activities in the eCTD publishing system, Lead/represent team in regulatory/submission meetings, Coordinate non-eCTD submissions with international teams
Seniority
Manager I, hands-on leadership