OSD Drug Product Development Lead; NDA & Process
Job in
Austin, Travis County, Texas, 78716, USA
Listed on 2026-07-09
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-09
Job specializations:
-
Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. is seeking a Director of Drug Product Development in Austin, Texas, to lead late-stage development and NDA-enabling activities for oral solid dosage form drug products. Responsibilities include ensuring robust, compliant, and inspection-ready products while acting as the Drug Product CMC lead.
The candidate should possess extensive experience (10-12 years) in OSD product development, regulatory submissions, and cross-functional collaboration. A PhD or MS in relevant fields is required, with a focus on leading a small team.
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