Director, OSD Drug Product Development & NDA Lead
Job in
Oklahoma City, Oklahoma County, Oklahoma, 73116, 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. is seeking a Director of Drug Product Development to lead late-stage OSD development and NDA-enabling activities for oral solid dosage forms.
The role oversees formulation, process development, scale-up, validation, and regulatory deliverables to support NDA submission and product launch. You will serve as the drug product CMC lead, guiding cross-functional teams and external CDMOs, ensuring robust, compliant, and inspection-ready products aligned with FDA/ICH
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