Associate Director, Regulatory CMC

Role: Develops and executes global regulatory CMC strategies for multiple vaccine products, leading preparation, review, and submission of CMC documentation for investigational and post-approval filings. Responsibilities: manages interactions with health authorities, provides regulatory guidance to cross-functional teams, and ensures compliance with EMA, FDA, ICH, and other global regulations. Leads CMC-related meetings with regulators, assesses product compliance, and monitors evolving regulatory requirements. Qualifications: Bachelor's in a scientific discipline; minimum 10 years in vaccine or biotech industries, with experience in CMC sections of BLA, IND, or IMPD submissions; proficiency with LIMS, SAP, TrackWise, Veeva; strong strategic, communication, and project management skills; advanced knowledge of regulatory guidelines. High-Value: vaccine development, biologics, biologic manufacturing, BLA and post-approval submissions, global regulatory compliance, CMC strategy, remote work with California-based salary range. Collaboration: reports to the Executive Director, CMC Regulatory; works across development, manufacturing, quality, and regulatory teams. Location: San Carlos, CA or US remote; work arrangement is remote.