Remote Senior Associate Director, CMC Regulatory Affairs

Artiva Biotherapeutics Inc.; San Diego (CA); Hybrid; USD 185,000 - 200,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) Retirement Plan

Paid Time Off

Bonus.ly recognition program

Company holidays

Life Insurance

Long Term Disability

Flexible Spending Account

Job summary

Artiva Biotherapeutics Inc. in San Diego, CA seeks an Associate Director of Regulatory Affairs, CMC to lead late-stage regulatory submissions and lifecycle activities for our NK cell therapy programs.

You will author Module 3/CTD content, coordinate with QA, Process Development, Manufacturing, and Clinical teams, and interact with FDA, EMA, and ex-US authorities to ensure compliant, timely filings. This role combines scientific rigor with strategic regulatory leadership.

Qualifications

• Bachelor’s degree in life sciences required; advanced degree preferred.
• 7 years of regulatory CMC experience in biopharmaceutical industry, with 3–5 years in cell therapy.
• Experience with BLA/MAA submissions strongly preferred.
• Independent author of CMC regulatory submissions (Module 3/CTD).
• Experience with lifecycle management CMC activities and post-approval filings.

Responsibilities

• Lead author and reviewer for CMC sections of late-stage/regulatory filings (BLAs/MAAs/INDs).
• Author Module 3/CTD content for drug substance, product, and analytics.
• Support lifecycle management and post-approval submissions.
• Coordinate with EMA, ANVISA, FDA on health authority interactions.
• Prepare meeting packages and agency responses.
• Ensure regulatory strategies meet global guidelines.

Skills

CMC regulatory experience

BLA/MAA submissions

Cell therapy knowledge

Cross-functional collaboration

Ex-US submissions

Regulatory writing

Project management

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Artiva Biotherapeutics Inc. in San Diego, CA seeks an Associate Director of Regulatory Affairs, CMC to lead late-stage regulatory submissions and lifecycle activities for our NK cell therapy programs.

You will author Module 3/CTD content, coordinate with QA, Process Development, Manufacturing, and Clinical teams, and interact with FDA, EMA, and ex-US authorities to ensure compliant, timely filings. This role combines scientific rigor with strategic regulatory leadership.