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Global Regulatory Strategy Leader - IND/NDA Submissions
Job in
Northern, Floyd County, Kentucky, USA
Listed on 2026-09-05
Listing for:
Otsuka Pharmaceutical Co., Ltd
Full Time
position Listed on 2026-09-05
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka Pharmaceutical Co., Ltd. seeks an experienced Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed prescription drugs, coordinating with the Global Regulatory Lead and cross‑functional teams.
You will manage submissions (INDs, NDAs/MAAs), regulatory intelligence, health authority interactions, and lifecycle activities, ensuring compliance with FDA/ICH and EDMS practices; travel approx. 20%.
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