Associate Director, Global Regulatory Affairs Strategy - Rochester, United States - Takeda Pharmaceutical

Description

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Job Description

Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs Strategy - Oncology in Cambridge, MA with the following requirements: Masters degree in Biotechnology, Biochemistry, Business, Science, or related field, or foreign academic equivalent, plus 4 years of related experience OR Bachelors degree in Biotechnology, Biochemistry, Business, Science, or related field, or foreign academic equivalent, plus 6 years of related experience. Required skills: Lead Global Regulatory team(s) in early as well as late-stage development of small molecules, biologics and gene therapy products for the treatment of various types of cancer and provide strategic regulatory advice to global project teams for the development of Target Product Profile and provide regulatory risk assessment for assigned products at different phases of development; serve as the primary point of contact with the FDA for assigned products and lead the preparation and submission of investigational new drug applications (INDs), clinical trial applications (CTAs), Pediatric study/investigation plans (PSP/PIP), Master Protocols, supplemental new drug application (NDA) and supplemental biologics license application (BLA), IND/NDA/BLA amendments and annual reports, study protocols, clinical study reports, investigator brochures, and safety reports; lead the project teams to global health authority interactions including Pre-IND, End-of-Phase, and Pre-NDA meetings with US FDA, Scientific Advice meetings with EMA, End-of-Phase and Pre-NDA consultations with PMDA in Japan and CDE in China; oversee, develop and mentor regulatory talent; lead rapid response to health authority request for information and assess health authority requests across the oncology portfolio to generate health authority query trends. Up to 25% domestic travel required. Up to 75% remote work allowed from anywhere in the U.S.

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EEO Statement

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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