Principal Pharmaceutical Scientist/ Research Fellow

This position is responsible for CMC activities as well as strategy for specific compounds at TPNA (US, EU,Canada, LA) in support of Takeda Pharmaceutical Company (TPC) and associated affiliates for the global development and regulatory approval of New Chemical Entities (NCE’s) and support of commercial product activities.

Responsibilities:
- Independently prepares the Chemistry, Manufacturing and Controls section of NDA or SNDA through direct interaction with TPC and TGRD Regulatory Affairs.
- Leads and authors CCMCS responses to regulatory agencies in an effort to obtain approval of applications filed such as: New Drug Applications, Supplemental Applications, Marketing Authorization Applications.
- Represents CCMCS at FDA/MHRA meetings, multiple development project teams and special TPNA initiatives.

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