- 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
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. #WeAreLilly **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
- 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
- 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
- Sumitomo Pharma (Indianapolis, IN)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable ... system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as… more