Senior Global Regulatory Lead, Submissions
Listed on 2026-10-10
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Pharmaceutical
Regulatory Compliance Specialist
Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to develop and execute global regulatory strategy for INDs, CTAs, and marketed products. You will coordinate submissions, manage lifecycle activities, and collaborate with GRL and teams to address health authority inquiries.
Strong communication, project management, and FDA/ICH expertise are essential to drive timely approvals and ensure regulatory compliance across global programs.
We invite applications for the Senior Global Regulatory Lead, Submissions position located in Helena, MT, United States.
Full responsibilities and requirements are described in the listing above.
Learn more about the Senior Global Regulatory Lead, Submissions role in the description above.
We appreciate your interest in this position.
Join Otsuka America Pharmaceutical Inc. and contribute to our ongoing work.
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