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Director of Regulatory Strategy
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- The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs.
- Represent the Regulatory Affairs department in multidisciplinary product development teams
- Lead preparation of global product development plans, target product profiles, orphan drug designation applications, and pediatric study plans
- Interface with the external Regulatory Operations group for document compilation and e-submission
- Assist in archival and maintenance of regulatory application submissions
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