- Lundbeck (South Bend, 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
- Corteva Agriscience (Indianapolis, IN)
- …our Global Headquarters in Indianapolis, IN. The Global Regulatory Leader (GRL) is accountable to lead regulatory teams to develop and implement ... of humankind. Corteva is seeking to a hire a ** Global Regulatory Leader ** to be...implementation of Corteva product development processes. + Accountable to lead global regulatory teams supporting… 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)
- …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
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.... regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory… more
- Lilly (Indianapolis, IN)
- …need them 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. We are a global healthcare leader headquartered in Indianapolis, Indiana.... regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.... regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory… more
- Parexel (Indianapolis, IN)
- …development of appropriate responses. * Participate in Safety Management Team (SMT) and Global Regulatory Team (GRT) meetings to provide expert input on ... tracked, and delivered. **Key Responsibilities:** * Serve as the global labelling lead for multiple products, providing...the idea of being a key player in a global regulatory role - apply today! \#LI-LB1… more
- Sumitomo Pharma (Indianapolis, IN)
- …will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is ... Lead , manage regional (United States and/or European) regulatory activities as part of a Global ...and project teams as needed + Collaborates effectively with regulatory operations leader (ROL) + Maintains professional… 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
- Sumitomo Pharma (Indianapolis, IN)
- …groups + Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process ... as directed. **_Manage and Develop Talent_** + Inspire and lead RA staff to ensure attainment of established goals...interests of the Company + Highly developed understanding of global regulatory dynamics + Unquestionable ethics, professional… more
- Sumitomo Pharma (Indianapolis, IN)
- … strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the ... governing the advertising and promotion of prescription drugs + Guide and/or lead regulatory agency interactions, including communications and meetings + Provide… more
- Lilly (Indianapolis, IN)
- …guidance to team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …environment. **Job Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory...assessments of new or updated guidance and regulations. + Lead regulatory public commenting process and posting… more
- Bausch + Lomb (Indianapolis, IN)
- …to continue leading the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...key stakeholders, and optimizing business outcomes. **Responsibilities:** + Formulate, lead , and drive integrated regulatory strategies across… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and ... data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory… more
- Lilly (Indianapolis, IN)
- …people management experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. + Experience leading a major ... discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the… more
- Lilly (Indianapolis, IN)
- …people management experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. + Prior experience with common ... discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the… more
- Lilly (Indianapolis, IN)
- …people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major ... discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the… more
