Manager, Regulatory Affairs
Dendreon
Location: Seal Beach, California, United States, United States
**Manager, Regulatory Affairs** at Dendreon (Seal Beach, California, United States) **What you'll do** - Develop and execute global CMC regulatory strategies for biologic products - Lead preparation and submission of regulatory applications and filings - Serve as primary Regulatory Affairs representative on cross-functional teams - Represent Regulatory Affairs in interactions with FDA and other health authorities **What they're looking for** - Experience with regulatory strategies for biologic, cell, and gene therapy products - Knowledge of preparing regulatory applications including INDs, BLAs, NDAs - Skills in providing regulatory guidance to cross-functional teams - Ability to monitor and interpret evolving regulatory requirements **Details** - Location: Seal Beach, California, United States - Type: On-site - Salary: null
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