- Sumitomo Pharma (Indianapolis, IN)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader… more
- United Therapeutics (Indianapolis, IN)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Responsibilities:** The Associate Director - Quality Assurance (QA) API External Manufacturing is ... of Quality projects, technology transfers, and commercialization. The API EM QA Associate Director is responsible for quality projects supporting API EM,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …data scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end statistical expertise ... approve tables, listings and graphs specifications. + Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance (QA) is responsible for managing ... (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Associate Director - QA is primarily responsible for the… more
- CSL Plasma (Indianapolis, IN)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (FDA). **Job Description** + Serves… more
- Lilly (Indianapolis, IN)
- …the world. The Associate QA-IDM (Auditor) will report to the Quality Associate Director and will have responsibility for assessing PDS functional areas, ... -Teamwork and interpersonal skills -5 years' experience in Quality and/or Regulatory Affairs Additional Preferences: -Auditor certification (ASQ CQA) and/or… more