Backed by 5AM Ventures.
About the role
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.
What they're looking for
- Bachelor’s degree required, advanced degree (MS, PhD, PharmD, or equivalent) preferred in life sciences, chemistry, biochemistry, or a related field
- Late-stage and/or commercial CMC regulatory experience is required. Demonstrated experience with BLA and/or MAA submissions strongly preferred
- Proven track record as a strong, independent author of CMC regulatory submissions (Module 3/CTD), with the ability to produce clear, scientifically rigorous documents with minimal supervision
- Hands-on experience with lifecycle management CMC activities, including post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reports
- Experience supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA, including preparation of meeting packages, briefing documents, and agency responses
- Excellent written communication skills, demonstrated ability to independently author, review, and edit regulatory documents to the highest scientific and editorial standards
More about this role
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK® , is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com .
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...
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