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Associate Director of Regulatory Affairs, CMC; Fully Remote
Remote / Online - Candidates ideally in
New York, New York County, New York, 10261, USA
Listed on 2026-10-02
New York, New York County, New York, 10261, USA
Listing for:
Unknown
Remote/Work from Home
position Listed on 2026-10-02
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Location: New York
- Supports late-stage development and commercial launch for a cell therapy pipeline.
- Provides hands-on CMC regulatory expertise globally.
- Authors CMC sections for BLAs, MAAs, IMPDs, and supplements.
- Manages lifecycle activities and health authority interactions.
- 7+ years CMC regulatory experience, including 3–5 years in cell therapy.
- Strong Module 3/CTD writing and FDA/EMA/ANVISA experience.
- Remote US role with competitive salary and comprehensive benefits.
- Medical, dental, vision, 401(k), and PTO included.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
For the Associate Director of Regulatory Affairs, CMC (Fully Remote) position at Unknown, we are reviewing applications now.
Join us at Unknown as our next Associate Director of Regulatory Affairs, CMC (Fully Remote) in United States.
Position Requirements
10+ Years
work experience
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