- Sanofi Group (Framingham, MA)
- …Leader leads a cross-functional CMC team with representatives from CMC Development, Manufacturing and Supply, Quality, Dossiers, Regulatory , Demand and ... the CMC contributions to pre-clinical, clinical and validation (DS/DP), and CMC elements for regulatory submissions and consultations. + He/she evaluates the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. * Provide strategic regulatory ... Team (PLRT) and in collaboration with US RA Labeling Content, provide CMC regulatory support during Annual, CCDS, or ad-hoc product labeling reviews for marketed… more
- Gilead Sciences, Inc. (Washington, DC)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
- Bausch + Lomb (Juneau, AK)
- …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
- ThermoFisher Scientific (Grand Island, NY)
- …expectations, and regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers using our materials ... or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year of prior experience… more
- Bausch + Lomb (Juneau, AK)
- …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