Artiva Biotherapeutics · 1 week ago
Sr. Director, Regulatory Affairs
San Diego, CA
Full-time
Onsite
Director/Executive
$240K/yr - $260K/yr
10+ years expArtiva Biotherapeutics is a clinical-stage biotechnology company focused on developing NK cell-based therapies for autoimmune diseases and cancers. The Senior Director of Regulatory Affairs will be responsible for regulatory submissions and ensuring compliance with global regulatory requirements, requiring expertise in cell and gene-modified cell therapy.
BiotechnologyLife ScienceTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's degree required
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
Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements
Preferred
Advanced degree preferred
Preferably late-stage development experience
Benefits
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.
Company
Artiva Biotherapeutics
Artiva Biotherapeutics is a biotech company focused on developing and commercializing allogeneic natural killer (NK) cell therapies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$198MKey Investors
Venrock Healthcare Capital Partners
2024-07-18IPO
2021-02-26Series B· $120M
2020-06-26Series A· $78M
Leadership Team
Fred Aslan
President and Chief Executive Officer
Neha Krishnamohan
Chief Financial Officer & EVP, Corporate Development
Recent News
2025-12-16
2025-11-15
2025-11-15
Company data provided by crunchbase