Senior Director, Regulatory Affairs
Artiva Biotherapeutics
full-time
Posted on:
Location Type: Office
Location: San Diego • California • United States
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Salary
💰 $240,000 - $260,000 per year
Job Level
About the role
- 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.
Requirements
- Bachelor’s degree required; advanced degree preferred.
- 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.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory filingsINDsCTAsBLAsMAAsCTD dossiersIBsclinical protocolsclinical study reportsregulatory compliance
Soft Skills
organizational skillsattention to detailcommunication skillscollaboration skillsability to manage multiple prioritiesadaptabilityability to thrive in fast-paced environment
Certifications
Bachelor's degreeadvanced degree