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Role Overview:
- Supports late-stage development and commercial launch for a cell therapy pipeline.
- Provides hands-on CMC regulatory expertise globally.
Key Responsibilities:
- Authors CMC sections for BLAs, MAAs, IMPDs, and supplements.
- Manages lifecycle activities and health authority interactions.
Requirements:
- 7+ years CMC regulatory experience, including 3–5 years in cell therapy.
- Strong Module 3/CTD writing and FDA/EMA/ANVISA experience.
Benefits:
- Remote US role with competitive salary and comprehensive benefits.
- Medical, dental, vision, 401(k), and PTO included.
Unknown
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.