- Parexel (Indianapolis, IN)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Parexel (Indianapolis, IN)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Lilly (Indianapolis, IN)
- …with analytical R&D, process development, manufacturing science, quality, and regulatory affairs to standardize data products. **Deliverables include:** ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Sumitomo Pharma (Indianapolis, IN)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Bausch + Lomb (Indianapolis, IN)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC...and regulatory excellence attributes as described in Global Regulatory Affairs white papers.… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead (GRL) ... The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC...and regulatory excellence attributes as described in Global Regulatory Affairs white papers.… more
