Associate Director, Regulatory Submission Management
Gilead
Responsibilities
- 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
Requirements
- 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
Vacancy posted 7 days ago
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