# Associate Director of Regulatory Affairs, CMC at Artiva Biotherapeutics

- Company: Artiva Biotherapeutics
- What the company does: Backed by 5AM Ventures.
- Company website: https://artivabio.com
- Type: Startups
- Level: Principal and up
- Location: Remote (US)
- Work setup: Remote
- Pay: $185K to $200K base salary per year (USD)
- Posted: 2026-09-24
- Apply by: 2026-11-08
- Apply: https://artivabio.bamboohr.com/careers/237
- Page: https://www.1752.vc/careers/jobs/artiva-biotherapeutics-associate-director-of-regulatory-affairs-cmc/

## About the role

​​ The Associate Director of Regulatory Affairs, CMC plays a critical role in supporting late-stage development, commercial launch, and lifecycle management activities for Artiva Biotherapeutics’ cell therapy pipeline. This individual is a strong, independent author of CMC regulatory submissions and a key contributor to global health authority interactions.

## What they're looking for

- Bachelor’s degree required, advanced degree (MS, PhD, PharmD, or equivalent) preferred in life sciences, chemistry, biochemistry, or a related field
- Late-stage and/or commercial CMC regulatory experience is required. Demonstrated experience with BLA and/or MAA submissions strongly preferred
- Proven track record as a strong, independent author of CMC regulatory submissions (Module 3/CTD), with the ability to produce clear, scientifically rigorous documents with minimal supervision
- Hands-on experience with lifecycle management CMC activities, including post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reports
- Experience supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA, including preparation of meeting packages, briefing documents, and agency responses
- Excellent written communication skills, demonstrated ability to independently author, review, and edit regulatory documents to the highest scientific and editorial standards