Artiva Biotherapeutics

Compliance

• Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory filings, including BLAs, MAAs, IMPDs, INDs, amendments, and supplements
• Author scientifically rigorous Module 3/CTD dossier content covering drug substance, drug product, and analytical sections
• Support commercial lifecycle management, including post-approval submissions, comparability protocols, CMC supplements, labeling updates, and annual product reviews
• Contribute to ex-US submissions, particularly EMA and ANVISA filings
• Prepare and coordinate FDA, EMA, and other health authority meeting packages, briefing documents, slide decks, and written responses
• Provide CMC regulatory input on process characterization, comparability studies, analytical method validation, and stability programs
• Compile, organize, and author regulatory documents and responses to health authority queries and deficiency letters
• Maintain knowledge of global CMC regulations and cell and gene therapy guidance
• Contribute to regulatory intelligence and best-practice initiatives
• Track regulatory commitments, submission timelines, annual reporting, and post-approval reporting obligations
• Work cross-functionally with Quality, Process Development, Manufacturing, Analytical Development, Clinical, and CMC leadership teams
• Provide informal mentorship and contribute to junior regulatory staff development

Associate Director of Regulatory Affairs, CMC