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Associate Director, Global Regulatory Affairs Project Management
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role:
- Associate Director, Global Regulatory Affairs Project Management, supporting late-stage oncology drug development and global regulatory submissions.
- manage regulatory submission processes from planning through filing, including INDs, CTAs, NDAs/MAAs;
- develop and track timelines;
- coordinate cross-functional teams (Regulatory Science, Clinical, CMC, Medical Writing, etc.);
- facilitate global regulatory strategies and agency interactions;
- build dashboards and improve project management tools.
- Bachelor's in life sciences;
- 12+ years in pharma/biotech, with 6-8+ years in regulatory project management;
- extensive experience in U.S. drug marketing applications;
- strong knowledge of global regulations, CTD structure, and cross-functional coordination;
- proficiency with project management tools (e.g., Smartsheet, MS Project).
- experience supporting global filings including Japan, Canada, EU/UK;
- oncology drug development background;
- familiarity with complex oncology trials.
- oncology, late-stage development, global regulatory submissions, cross-functional leadership, project management expertise.
- not specified.
Position Requirements
10+ Years
work experience
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