Director / Senior Director of Regulatory Operations

Job Summary:
The Director / Senior Director of Regulatory Operations is responsible for building, leading, and scaling the regulatory operations function across Artiva’s NK cell-based therapies. Own end-to-end submission planning, execution, and delivery for global regulatory applications and serve as the enterprise owner of the regulatory information management platform. On-site or remote.

Duties/Responsibilities:
- Build, lead, and scale Regulatory Operations; establish processes, infrastructure, and best practices.
- Own end-to-end project planning and management for all regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, supplements, annual reports) across global markets.
- Serve as regulatory information management system owner.
- Partner cross-functionally to develop integrated regulatory project plans, timelines, and risk mitigation.
- Lead cross-functional submission teams to ensure zero-defect filings.
- Develop tracking dashboards/KPIs; escalate risks and present status to senior leadership.
- Author/maintain SOPs, work instructions, and templates for submission lifecycle and publishing/QC.
- Ensure compliance for electronic submissions (eCTD formatting, validation, publishing) across US, EU, Canada, and other markets.
- Provide strategic input on regulatory pathways (Accelerated Approval, Breakthrough Therapy, Orphan Drug, expedited programs).
- Manage and develop direct reports; recruit, mentor, and build the team.

Professional Experience/Qualifications:
- Bachelor’s degree required; advanced degree preferred.
- 15+ years regulatory affairs/operations/project management in biopharma/biotech; 5+ years leadership.
- Proven zero-defect end-to-end regulatory submissions (INDs, NDAs/BLAs, MAAs) without major deficiencies/delays.
- Deep expertise with Veeva Vault RIM (Submissions/Archive/Registrations) and administration/implementation.
- Strong eCTD knowledge (structure, publishing, validation) across US/EU and other markets.
- Experience building regulatory operations teams in fast-paced growth-stage companies.
- Experience with FDA expedited programs (Accelerated Approval, Breakthrough Therapy, Orphan Drug) preferred.
- Hands-on preparation/submission of INDs, CTAs, BLAs, MAAs.
- Excellent communication/collaboration; adapt to changing regulatory requirements.

Benefits/Compensation:
- Base Salary: $205,000 - 268,000.
- Medical, Dental, Vision; Group Life; LTD; 401(k); EAP; FSA; PTO; company paid holidays; Bonus.ly recognition program.