- 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
- Bristol Myers Squibb (Indianapolis, IN)
- …and external stakeholders . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, ... to shaping and advancing our Chemistry, Manufacturing, and Controls ( CMC ) strategy **Job Responsibilities** Essential duties and responsibilities include the… 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
- 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
- Merck (Indianapolis, IN)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... transfer of process and product knowledge with reduced error rates Digital CMC will implement digital solutions to install the foundational capabilities needed to… more
- Lilly (Indianapolis, IN)
- …highly desirable. + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership ... in a collaborative and fast-paced work environment. + Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs,… 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)
- …+ Collaborate with internal stakeholders (eg, Discovery, Analytical, Drug Product, Quality, Regulatory , CMC PM) and external CDMOs to align and execute ... ADC payloads, linkers, and conjugates in development labs. + Contribute to regulatory submissions (IND, IMPD, BLA/MAA), authoring high-quality CMC sections. +… more
- Lilly (Indianapolis, IN)
- …Clinical Supply and Delivery organization, external clinical and regulatory vendors, regulatory colleagues in GRA, GOLD, and GRA- CMC and when necessary, ... trial sponsor in recent years. The role of the Clinical Trial Label Regulatory Compliance Associate is to participate in maintenance and interpretation of the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more