Artiva Biotherapeutics

Compliance

• Support the preparation, review, and submission of regulatory filings, including INDs, CTAs, BLAs, and MAAs, ensuring compliance with global regulatory requirements.
• Assist in compiling and organizing regulatory documents and responding to health authority queries.
• Work closely with cross-functional teams, including Clinical, Pharmacovigilance, Biometrics, and CMC, to ensure accurate and complete regulatory submissions.
• Maintain up-to-date knowledge of global regulatory requirements and contribute to regulatory intelligence efforts.
• Support regulatory interactions with global health authorities by preparing meeting materials and responses to requests.
• Contribute to the development of regulatory documentation, including CTD dossiers, IBs, clinical protocols, nonclinical and clinical study reports.
• Assist in tracking regulatory commitments and timelines to ensure timely submissions and approvals.
• Provide hands-on support in assessing emergent clinical data and operational activities for regulatory compliance.

Senior Director, Regulatory Affairs