- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as… more
- Merck & Co. (Rahway, NJ)
- …interacts with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more our ... The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize label… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... that DS is prepared to meet new or proposed global regulatory requirements and that DS has...should prioritize external engagement efforts for maximum impactDefines a global strategy for achieving policy-shaping objectives (eg… more
- Insmed Incorporated (Bridgewater, NJ)
- …expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed marketed and ... project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for...in the pharmaceutical industry, 7+ years of experience in global regulatory labeling Full understanding of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality ... to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy ... Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global Customer Marketing and Commercial Execution to ensure optimized and successful… more
- Merck & Co. (Rahway, NJ)
- …of commercialization, including product development team, target product profile development, global regulatory filing strategy , launch readiness reviews, ... Job DescriptionWe have an exciting Director opportunity to join our global ...Global Asset Lead to develop the Integrated Business Strategy by actively synthesizing inputs from cross-functional teams including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of ... procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best ... and future investments.Responsibilities- Oversees bioanalysis strategy from global development and global regulatory ... strategy from global development and global regulatory perspectives- Facilitates/oversees global … more
- Eisai, Inc (Nutley, NJ)
- …readiness and resolution.Align IT compliance budget with risk appetite and global strategy .Educate end-users on IT compliance requirements.Oversee business ... to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of high dollar… more
- Merck & Co. (Durham, NC)
- …Capital project management experience Risk Management experience Experience supporting regulatory inspections- Change Execution Management / Strategy Realization ... We work in the local plant connected to our global manufacturing network to ensure the highest quality of...substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… more
- Merck & Co. (Millsboro, DE)
- …11, Good Manufacturing Practices, Computer Systems Assurance, track and trace, and other global regulatory requirements that impact IT and OT systems in ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site...The Site Digital Technology Lead is the representative for Global Animal Health Manufacturing IT (GAHM IT) on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from supervisor. Represents statistics function to Health Authorities meetings as needed.- Global BDO Strategy to Improve Drug Development: Leads global ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
