- Lundbeck (Indianapolis, IN)
- …that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than ... in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with… more
- Lundbeck (Fort Wayne, IN)
- …that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than ... Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with… more
- Rolls Royce (Indianapolis, IN)
- …participate in product level safety boards and in-service reviews with regulatory and airworthiness authorities Provide technical support to help resolve technical ... queries and operational arisings Lead investigations and identify root cause and corrective action for in-service events Engage with customers and devise technical… more
- Lilly (Indianapolis, IN)
- …**Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in… more
- Lilly (Indianapolis, IN)
- …**Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is... submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + Regulatory experience… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- Sumitomo Pharma (Indianapolis, IN)
- …will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is ... in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the… more
- Parexel (Indianapolis, IN)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders. * Lead impact assessments for technical and global labeling changes across… more
- Lilly (Indianapolis, IN)
- …EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues** + Works with numerous ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....Lead inspection readiness activities + Serve as a global compliance CGMP expert providing feedback in preparation for… more
