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Regulatory Affairs Lead — FDA Liaison & CMC Expert

Job in Madison, Morris County, New Jersey, 07940, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-01-29
Job specializations:
  • Healthcare
  • Pharmaceutical
Job Description & How to Apply Below
A pharmaceutical company is seeking a US Agent responsible for communication with the FDA and manufacturing sites. The role includes leading the CMC team, ensuring compliance with FDA guidelines, and managing regulatory correspondence. Candidates should have an MS in Life Sciences and 4-5 years of experience in FDA regulatory management within the generic pharmaceutical sector. Strong communication skills and teamwork abilities are essential for success in this position.
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