Associate Director, Regulatory Affairs, CMC

About Artiva

About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.

AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.

Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.

Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.

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Job Summary: The Associate Director of Regulatory Affairs, CMC plays a critical role in supporting late-stage development, commercial launch, and lifecycle management activities for Artiva Biotherapeutics’ cell therapy pipeline. This individual is a strong, independent author of CMC regulatory submissions and a key contributor to global health authority interactions. The ideal candidate brings hands-on late-stage and commercial CMC regulatory experience in cell therapy (allogeneic and/or autologous), deep familiarity with late-stage CMC operations and study design, and a proven track record authoring BLA/MAA submissions and post-approval lifecycle dossiers.

Working cross-functionally with Quality, Process Development, Manufacturing, and Clinical teams, this role ensures that regulatory strategies and submissions meet the highest scientific and compliance standards across global jurisdictions.

• Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory filings, including BLAs, MAAs, IMPDs, INDs, and associated amendments and supplements. Author clear, scientifically rigorous Module 3/CTD dossier content across drug substance, drug product, and analytical sections.
• Support commercial lifecycle management activities, including authoring and reviewing post-approval submissions, comparability protocols, CMC supplements, labeling updates, and annual product reviews for cell therapy (allogeneic and/or autologous) products.
• Contribute to ex-US regulatory submissions with a primary focus on EMA (MAA, Scientific Advice, post-approval variations) and ANVISA, ensuring dossiers meet jurisdiction-specific formatting and content requirements.
• Prepare and coordinate formal health authority meeting packages, including Type A/B/C meetings with FDA, Scientific Advice requests with EMA, and formal interactions with ex-US jurisdictions. Author meeting briefing documents, slide decks, and high-quality written responses to agency questions.
• Partner with Process Development, Analytical Development, Manufacturing, and Quality teams to provide CMC regulatory input on late-stage development activities and study designs, including process characterization, comparability studies, analytical method validation, and stability programs.
• Compile, organize, and author regulatory documents; prepare high-quality written responses to health authority queries and deficiency letters from FDA and ex-US jurisdictions.
• Maintain current knowledge of evolving global CMC regulations and cell and gene therapy-specific guidance documents (FDA, EMA, ICH, ANVISA);…