- Otsuka America Pharmaceutical Inc. (Albany, NY)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution ... of global investigational submissions and manages lifecycle regulatory activities for assigned Clinical Trial Application projects in alignment with the Global … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA , NDA or BLA, MAA). - RAC ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …program(s) forward from pre-IPA nomination through BLA application, including multiple pre-IND/ CTA molecules under development and new indications and life cycle ... program therapeutic area development strategies inclusive of research, clinical, regulatory , supply (includes tox, clinical and commercial materials) and commercial… more
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