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Salary: USD 260,000 - 275,000 / annual
Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for patients with autoimmune diseases. The company's lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies.
The Senior Director of Regulatory Affairs will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions, and ensuring compliance with global regulatory requirements. This role reports directly to leadership and manages the regulatory strategy for the company's cell therapy pipeline.
Key responsibilities include:
- Primary authorship and support for regulatory filings including INDs, CTAs, BLAs, and MAAs, ensuring compliance with global regulatory requirements
- Preparation, review, and submission of regulatory filings with health authorities
- Compilation and organization of regulatory documents and responses to health authority queries
- Cross-functional collaboration with Clinical, Pharmacovigilance, Biometrics, and CMC teams to ensure accurate and complete regulatory submissions
- Maintenance of current knowledge of global regulatory requirements and contribution to regulatory intelligence efforts
- Preparation of meeting materials and responses for regulatory interactions with global health authorities
- Development of regulatory documentation including CTD dossiers, Investigator's Brochures, clinical protocols, and nonclinical/clinical study reports
- Tracking of regulatory commitments and timelines to ensure timely submissions and approvals
- Assessment of emergent clinical data and operational activities for regulatory compliance
The company emphasizes a collaborative, innovative culture with flat communication structures and a commitment to making cell therapies broadly accessible to patients.
REQUIREMENTS:
- Bachelor's degree required; advanced degree preferred
- 10+ years' experience in a fast-paced, high-volume document production environment (documentation, publications, formal meetings)
- At least 5 years' experience in the cell and gene therapy space
- Strong knowledge of regulations and guidelines across multiple global jurisdictions (U.S., EU, and other key regulatory agencies)
- Hands-on experience in preparation and submission of regulatory filings (INDs, CTAs, BLAs, MAAs)
- Strong organizational skills and attention to detail with ability to manage multiple priorities
- Excellent written and verbal communication and collaboration skills
- Ability to thrive in fast-paced environment and adapt to changing regulatory requirements
