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Director, OSD Drug Product Development & NDA Readiness

Job in Concord, Merrimack County, New Hampshire, 03306, USA
Listing for: Otsuka America Pharmaceutical Inc.
Full Time position
Listed on 2026-07-29
Job specializations:
  • Pharmaceutical
    Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Pharma Engineer, Pharmaceutical Science/ Research
Salary/Wage Range or Industry Benchmark: 186489 - 278875 USD Yearly USD 186489.00 278875.00 YEAR
Job Description & How to Apply Below

Otsuka America Pharmaceutical Inc. seeks a Director, Drug Product Development to lead late-stage development and NDA‑enabling activities for oral solid dosage forms.

You will execute formulation, process development, scale‑up, validation, and regulatory deliverables to support NDA submission, regulatory review, and commercial launch. As Drug Product CMC lead, you will work cross‑functionally with internal teams and external CDMOs, drive risk assessment, tech transfer, and inspection readiness,

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