- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructively challenge teams to… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC teams to… more
- Sumitomo Pharma (Indianapolis, IN)
- …Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
- Lilly (Indianapolis, IN)
- …experience, the Cardiovascular/Cardiometabolic Business Unit - Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is an ... here includes patients, providers (HCPs) and payers. The Senior/Executive Director may also work closely with global ...the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies… more
- Lilly (Indianapolis, IN)
- …a strategic liaison between Global Quality and business units (eg, regulatory affairs , manufacturing, IT) to ensure metric relevance and adoption.** **Enable ... make life better for people around the world. **Position Summary:** **The Associate Director - Global Quality Management Review Lead will drive the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more