Late-Stage Drug Product & Process Development Lead
Job in
Frankfort, Franklin County, Kentucky, 40601, USA
Listed on 2026-07-10
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-10
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Manufacturing
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. seeks an Associate Director to lead late-stage drug product development from Phase 2/3 through commercialization and beyond. You will provide technical oversight for manufacturing, scale‑up, tech transfer, PPQ, and lifecycle management strategies.
The role requires strong regulatory experience with NDA/CMC submissions, QbD integration, and cross-functional collaboration across Regulatory, Quality, Manufacturing, and Clinical teams.
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