- Lilly (Indianapolis, IN)
- …Process Development, Engineering, Analytical, Quality, Supply Chain and Raw Materials, and Regulatory Affairs . + Represent the PTE team during regulatory ... + Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech transfer.… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead (GRL) ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share … more
- Lilly (Indianapolis, IN)
- …team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the Chemistry, ... and working across functional and geographical boundaries.** **Knowledge of the international regulatory framework.** **Demonstrated ability to identify root… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Senior Director, Medical Communications, CNS directs and provides...accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position… more
- Lilly (Indianapolis, IN)
- …the business. RLT also provides regulatory law advice to Global Regulatory Affairs , Manufacturing & Quality, Global Patient Safety, Clinical Development and ... around the world. **Organization Overview:** This position will be part of the Regulatory Legal Team (RLT), which reports up through Lilly's General Counsel and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific ... accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology… more
- Lilly (Indianapolis, IN)
- …Serve as a liaison between construction teams, manufacturing operations, engineering, and regulatory affairs to ensure alignment and timely decision-making. + ... for clinical trial medicines, while also reducing costs and environmental impact. The Senior Principal Engineer - Automation Engineering will work as a member of the… more
- Lilly (Indianapolis, IN)
- …or experience in drug discovery or development, eg epidemiology, toxicology, pharmacovigilance, regulatory affairs . OR (BS Degree or equivalent experience in ... or experience in drug discovery or development, eg epidemiology, toxicology, pharmacovigilance, regulatory affairs . + Experience in drug development process. +… more
- Lilly (Indianapolis, IN)
- …spanning the United States and key Asian markets. The AVP will partner with senior R&D and business leaders to transform how technology enables patient safety and ... modernization of our safety technology landscape to meet evolving regulatory requirements and business needs. + **Service Management Transformation utilizing… more
- Lilly (Indianapolis, IN)
- …processes and product quality. * Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs , and Supply Chain teams to ensure seamless ... from development to manufacturing, ensuring successful scale-up, validation, and regulatory compliance. * Design, execute, and interpret experiments to optimize… more