Backed by 5AM Ventures.
About the role
The Senior Director of Regulatory Affairs is responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. The ideal candidate will have a strong background in cell and gene-modified cell therapy, expertise in global regulatory requirements, and preferably late-stage development experience.
What they're looking for
- Bachelor’s degree required, advanced degree preferred
- 10+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, formal meetings) with at least 5 in the cell and gene therapy space
- Strong knowledge of regulations and guidelines across multiple global jurisdictions, including the U.S., EU, and other key regulatory agencies
- Hands-on experience in the preparation and submission of regulatory filings (e.g., INDs, CTAs, BLAs, and MAAs)
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities effectively
- Excellent written and verbal communication and collaboration skills to work effectively with cross-functional teams
More about this role
About Artiva
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, create an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com
Join Artiva Biotherapeutics in San Diego and work directly on the manufacturing floor to produce our innovative, off-the-shelf cell therapies in a state-of-the-art cGMP facility. Apply your expertise across cell culture, aseptic processing, harvest and fill-finish, playing a direct role in advancing therapies for patients with autoimmune diseases.
For more information, visit www.artivabio.com .
The Senior Director of Regulatory Affairs is responsible for...
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