Director, OSD Drug Product Development & NDA Readiness
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-07-11
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-11
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. seeks a Director to lead late-stage drug product development for oral solid dosage forms, overseeing CMC strategies, scale-up, and regulatory deliverables to support NDA submissions and commercial launch.
The role requires cross-functional leadership, external CDMO collaboration, and ensuring inspective readiness across development, manufacturing, and regulatory activities.
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