- Lilly (Indianapolis, IN)
- …life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Lilly (Indianapolis, IN)
- …that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… 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. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge ... and regional/local affiliate requirements. The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and… more
- Lilly (Indianapolis, IN)
- …regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable ... and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and… more
- Bausch + Lomb (Indianapolis, IN)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management… more
- Lilly (Indianapolis, IN)
- …data to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies. + Identify, partner and develop ... as purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials and regulatory submissions of… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
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