Associate Director, Regulatory Submission Management

Gilead Sciences · Foster City, CA

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RegulatoryFull-time$182k–$236kCompany career page

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What they're looking for

Extensive regulatory affairs experience with global submission management
Demonstrated expertise managing complex NDAs, MAAs, BLAs, and related filings
Strong project management and cross-functional coordination skills
Knowledge of health authority requirements and regulatory pathways
Proven ability to manage multiple major submissions simultaneously
Leadership experience in process improvement and regulatory initiatives

What you'll be doing

Direct planning and execution of highly complex global regulatory submissions and programs
Partner with Regulatory Affairs Liaisons to develop and maintain global filing plans with regulatory milestones
Oversee submission lifecycle execution and ensure deliverables meet technical specifications and timelines
Manage 2-4 major regulatory submissions including NDAs, MAAs, BLAs, and other application types
Facilitate cross-functional regulatory team communications and coordinate meetings across multiple stakeholder groups

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Date posted4 days ago

Last source check1 day ago

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