Job Summary:
The Director / Senior Director of Regulatory Operations is responsible for building, leading, and scaling the regulatory operations function across Artiva's growing portfolio of NK cell-based therapies. This role owns end-to-end submission planning, execution, and delivery for all global regulatory applications and will serve as the enterprise owner of our regulatory information management platform. The ideal candidate will bring deep expertise in eCTD submissions, regulatory information management systems, and cross-functional project leadership in a fast-paced biotech environment, with preference for experience in cell therapy or biologics. This role can be on-site or remote.
Duties/Responsibilities:
- Build, lead, and scale Regulatory Operations at Artiva, establishing processes, infrastructure, and best practices to support Artiva's expanding clinical and commercial portfolio.
- Own end-to-end project planning and management, and on-time delivery of all regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, supplements, and annual reports) across global markets.
- Serve as the regulatory information management system owner.
- Partner with Regulatory Affairs Leads, Clinical Development, CMC, Pharmacovigilance, Project Management and Program Lead to develop and maintain integrated regulatory project plans, timelines, and risk mitigation strategies.
- Lead cross-functional submission teams composed of internal stakeholders and external consultants; drive alignment, accountability, and execution to ensure zero-defect filings.
- Develop and maintain real-time tracking dashboards and KPI reporting; proactively escalate risks and present submission status to senior leadership.
- Author and maintain SOPs, work instructions, and templates governing the regulatory submission lifecycle, document management, and publishing/QC processes.
- Ensure compliance with global regulatory requirements for electronic submissions, including eCTD formatting, validation, and publishing standards across US, EU, Canada, and other markets.
- Provide strategic input on regulatory pathways, including Accelerated Approval, Breakthrough Therapy, Orphan Drug, and other expedited programs relevant to Artiva's pipeline.
- Manage and develop direct reports; recruit, mentor, and build a high-performing regulatory operations team.
Professional Experience/Qualifications:
- Bachelor's degree required; advanced degree preferred.
- 15+ years' experience in Regulatory Affairs, Regulatory Operations, and/or Regulatory Project Management within the biopharmaceutical or biotechnology industry, with at least 5 years in a leadership role.
- Proven track record of leading end-to-end regulatory submissions (INDs, NDAs/BLAs, MAAs) with zero filing deficiencies, refuse-to-file actions, or delays.
- Deep expertise with Veeva Vault RIM (Submissions, Archive, and/or Registrations modules) or similar platform, including hands-on implementation and administration experience.
- Strong knowledge of eCTD structure, publishing, and validation requirements across US (FDA), EU (EMA), and other global markets.
- Demonstrated success building and managing regulatory operations teams in fast-paced, growth-stage biotech or pharmaceutical companies.
- Experience supporting programs utilizing FDA Accelerated Approval, Breakthrough Therapy Designation, Orphan Drug Designation, or other expedited regulatory pathways.
- Hands-on experience in the preparation and submission of regulatory filings (e.g., INDs, CTAs, BLAs, and MAAs).
- Excellent written and verbal communication and collaboration skills to work effectively with cross-functional teams.
- Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements.
Depending on where we land on level I think we can lower this but cannot remember the exact number for AD/D?
In addition to a great culture, we offer:
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $205,000 - 268,000. Exact compensation may vary based on level, skills and experience.
