- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position ... of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... 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 medicines 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 ... 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 patients… more
- Lilly (Indianapolis, IN)
- …regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable ... around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… 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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Lilly (Lebanon, IN)
- …trial medicines, while also reducing costs and environmental impact. The Senior Director , Process Translation and Execution is directly responsible for managing the ... hybrid and biologics operations with onsite lab capabilities. The Senior Director Process Translation & Execution will be responsible for providing technical,… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams… more
- Lilly (Indianapolis, IN)
- …lifecycle of an asset ranging from the discovery/development interface through regulatory submission and post-approval changes. We work to improve patient outcomes ... saving therapeutics. **Role Overview:** We are seeking a veteran and visionary Sr. Director of Early Phase Chemistry to join our leadership team. This individual… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing ... optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity… more