- Lilly (Indianapolis, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global ... issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems. +… more
- Roche (Indianapolis, IN)
- …medical affairs, legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or cross-chapter ... where every voice matters. **The Position** **The Opportunity** The Regulatory Compliance Director is a people leader...keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.… more
- Sumitomo Pharma (Indianapolis, IN)
- …developing and maintaining the development core data sheet (DCDS) if required + Ensure compliance with global regulatory requirements and adherence to ... regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide strategic review of dossier… more
- Sumitomo Pharma (Indianapolis, IN)
- …works closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to ... regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide updates to the Global … 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 ... ensure attainment of established goals and objectives + Ensure global compliance with all relevant internal and...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 ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses,… more
- Stryker (Columbia City, IN)
- …designed for trauma and extremity procedures. **What you will do** + Assess global trends, stakeholder concerns, and regulatory issues to inform strategy. + ... Develop and update global and regional regulatory strategies aligned with...non-government organizations affecting market access. + Develop and manage regulatory procedures, SOPs, and training programs for compliance… more
- Reckitt (Evansville, IN)
- Regulatory Manager City: Evansville **We are Reckitt** Home...pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in ... of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With… more
- Stryker (Columbia City, IN)
- …experience in the medical device industry. **What you will do** + Assess regulatory intelligence to inform global and regional strategy development for trauma ... and extremities products. + Evaluate regulatory environments and advise on compliance throughout the product lifecycle. + Anticipate regulatory obstacles and… more
- Lilly (Indianapolis, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....experience. + Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. + Experience… more
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