Director, OSD Drug Product Development & NDA Lead
Job in
Jackson, Hinds County, Mississippi, 39200, USA
Listed on 2026-07-30
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-30
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. is seeking a Director of Drug Product Development to lead late‑stage development and NDA‑enabling activities for oral solid dosage forms.
You will oversee formulation, process development, scale‑up, validation, and regulatory deliverables to support NDA submissions and commercial launch. The role requires cross‑functional leadership, external CDMO management, risk assessment, and ensuring FDA/ICH compliance.
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