- Parexel (Indianapolis, IN)
- …excellence and innovation in post-marketing activities. Key Responsibilities - Develop and lead global post-approval regulatory strategies for assigned ... **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a...with a passion for navigating the complex world of global regulatory affairs? Do you thrive in… more
- 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
- Parexel (Indianapolis, IN)
- …(QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and ... the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective and Preventive Actions… more
- Parexel (Indianapolis, IN)
- …role.** We're currently seeking a highly experienced Clinical Regulatory Leader , Health Authority Medical Review Team Lead , Master/Senior Medical Review ... patients worldwide. You will: - Lead strategic regulatory initiatives across diverse product types and global...matter experts - Represent Parexel as a visible thought leader in the industry - Meet new situations and… more
- Parexel (Indianapolis, IN)
- …sponsor (ie: tasks and time per task contracted) and according to the assigned role ( Global Lead Physician GLP or Regional Lead Physician RLP). Medical ... your Rheumatology experience and Lupus expertise to an Industry Leader , Parexel!** In anticipation of future needs, we are...Medical Sciences Team as we continue to grow our Global Immunology and Inflammation Therapeutic Franchise! As an Associate… more
- 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
- iCIMS (Indianapolis, IN)
- …looking for an experienced and strategic Principal GRC Security Analyst to help lead our Governance, Risk, and Compliance efforts. In this role, you'll work ... When you join iCIMS, you join the team helping global companies transform business and the world through the...+ Provide leadership and act as key stakeholder of regulatory and compliance initiatives (eg ISO 27001, SOC 2,… more
- Ralliant (Indianapolis, IN)
- …+ Shape requirements and influence specifications during early engagement. + Lead customer Q&A, pricing discussions, and proposal clarifications in partnership with ... of the US defense acquisition process, contracting vehicles, and regulatory requirements (FAR/DFARS, ITAR). + Exceptional interpersonal and communication skills,… 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
- 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)
- …for people who are determined to make life better for people around the world. Global Regulatory Policy & Strategy strives to enable Lilly to deliver innovative ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....drug development. The purpose of the Senior Director - Global Regulatory Affairs (GRA) Global … 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
- Coinbase (Indianapolis, IN)
- …* Work with trade groups to establish consensus industry positions on alternative regulatory approaches * Organize and lead external engagements with regulators ... emerging onchain platform - and with it, the future global financial system. To achieve our mission, we're seeking...in a fast-paced environment supporting a wide variety of regulatory advocacy and the development of new policy positions,… more
- Parexel (Indianapolis, IN)
- …excellence and innovation in post-marketing activities. Key Responsibilities * Develop and lead global post-approval regulatory strategies for assigned ... **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a...with a passion for navigating the complex world of global regulatory affairs? Do you thrive in… 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
