- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality ... and Controls ( CMC ) business function.** **The role ensures compliance with regulatory standards and drives quality excellence across GRA processes. In… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... regulatory strategies in collaboration with other regulatory , Manufacturing, Quality and project personnel to… more
- Lilly (Indianapolis, IN)
- …all over the world. The Senior Advisor /Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... regulatory strategies in collaboration with other regulatory , manufacturing, quality and project personnel to… more
- Lilly (Indianapolis, IN)
- …across internal CMC networks (Drug Product Delivery, Project Management, Quality , Manufacturing, and Regulatory ) to implement and deliver material and ... (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected + Experience with… more
- Lilly (Indianapolis, IN)
- …to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies. + Engage the external ... with other Lilly chemists, analytical chemists, bioconjugation scientists, engineers, CMC project management, Lilly manufacturing partners, and regulatory … more
- Lilly (Indianapolis, IN)
- …procedures, data requirements and summaries. + Author technical reports and CMC related documents including sections in regulatory submission documents ... through the use of mechanistic thinking, modeling and data rich experimentation. The Advisor / Senior Advisor will collaborate with a diverse cross-functional… more
- Lilly (Indianapolis, IN)
- …of technical information with, but not limited to, Safety, Environmental and Quality Team members, Purification Development colleagues, CMC Team members, ... members, Analytical Services, Tech Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel. Especially important, in this role,… more
- Bausch + Lomb (Indianapolis, IN)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... CMC and clinical/non-clinical, labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key… more