Associate Director, Global Regulatory Affairs Project Management

Role:

• Associate Director, Global Regulatory Affairs Project Management, supporting late-stage oncology drug development and global regulatory submissions.

Responsibilities:

• 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.

Requirements:

• 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).

Preferred:

• experience supporting global filings including Japan, Canada, EU/UK;
• oncology drug development background;
• familiarity with complex oncology trials.

HighValue:

• oncology, late-stage development, global regulatory submissions, cross-functional leadership, project management expertise.

WorkSetup:

• not specified.