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Senior Lead, Drug Product & Process Development; Late-Stage

Job in Little Rock, Pulaski County, Arkansas, 72208, USA
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
Salary/Wage Range or Industry Benchmark: 169222 - 253000 USD Yearly USD 169222.00 253000.00 YEAR
Job Description & How to Apply Below
Position: Senior Lead, Drug Product & Process Development (Late-Stage)

Otsuka America Pharmaceutical Inc. is seeking an Associate Director for Drug Product & Process Development to provide technical and strategic leadership for late-stage programs from Phase 2/3 through commercialization and beyond.

You will serve as a CMC lead on NDA filings, oversee scale-up, tech transfer, and PPQ activities, and ensure strategies align with QbD and global regulatory expectations. Collaboration with regulatory, quality, manufacturing, and commercial teams is essential.

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Position Requirements
10+ Years work experience
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