- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- 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. (Tallahassee, FL)
- …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
- University of Miami (Miami, FL)
- …Miami, FL CORE JOB SUMMARYThe Regulatory Analyst 3 - UHealth assists the Regulatory Manager and/or Director of Regulatory with the day-to-day operations ... recommend, and implement + corrective and preventive actions for regulatory with the guidance of senior leadership....+ Draft Budget (if applicable) + Clinical Trial Agreement ( CTA ) + Patient documents (if applicable) + Recruitment materials… more
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