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Global Regulatory Strategy Lead – IND/NDA Submissions
Job in
Denver, Denver County, Colorado, 80285, USA
Listed on 2026-07-30
Listing for:
Otsuka America Pharmaceutical Inc.
Full Time
position Listed on 2026-07-30
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Otsuka America Pharmaceutical Inc. in Denver seeks an experienced regulatory affairs professional to develop and execute regulatory strategy for global submissions and lifecycle management of assigned programs under the guidance of the Global Regulatory Lead.
You will translate global requirements, assess regulatory challenges, and collaborate with the GR team to address health authority queries and ensure compliant, timely filings across INDs, CTAs, NDAs or BLAs where applicable.
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