Global Regulatory Submissions Lead

Artiva Biotherapeutics Inc.; San Diego (CA); Remote; USD 260,000 - 275,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

EAP

FSA

PTO

Paid holidays

Bonus.ly rewards

Job summary

Artiva Biotherapeutics Inc. is seeking a Senior Director of Regulatory Affairs to lead regulatory submissions and strategy for global programs on the cell therapy platform.

You will prepare CTDs, IBs, and clinical protocols while ensuring compliance across U.S., EU, and other major markets. Ideal candidates bring 10+ years in regulatory affairs within cell or gene therapy, with leadership experience and a track record in late-stage development.

Qualifications

• Knowledge of global regulatory requirements (US, EU, other regions).
• Experience preparing and submitting INDs, CTAs, BLAs, MAAs.

Responsibilities

• Lead preparation, review, and submission of regulatory filings (INDs/CTAs/BLAs/MAAs).
• Organize regulatory documents and respond to health authority inquiries.
• Collaborate with Clinical, Pharmacovigilance, Biometrics, and CMC teams for submissions.
• Maintain up-to-date knowledge of global regulatory requirements and intelligence.

Skills

Regulatory affairs knowledge

Regulatory submissions

Cross-functional collaboration

Attention to detail

Project management

Education

Bachelor’s degree

Advanced degree

Job description

Artiva Biotherapeutics Inc. is seeking a Senior Director of Regulatory Affairs to lead regulatory submissions and strategy for global programs on the cell therapy platform.

You will prepare CTDs, IBs, and clinical protocols while ensuring compliance across U.S., EU, and other major markets. Ideal candidates bring 10+ years in regulatory affairs within cell or gene therapy, with leadership experience and a track record in late-stage development.