- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for providing oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ... Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or global … more
- Merck & Co. (Rockville, MD)
- Job DescriptionThe Global Regulatory Policy & Intelligence (GRPI) team advocates for regulatory policy that supports our company's business goals, developing ... in partnership with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and… 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)
- …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
- 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
- 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)
- …leader engagement execution, target product profile development, health authority interactions, global regulatory filing strategy , organized customer ... Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to...input on such activities as:target product profile (TPP) development, global regulatory filing strategy , launch… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Oncology Communications The role of Director , Global Communications, Oncology is a unique opportunity to join our Company, a ... role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced...audiences in alignment with the company's corporate narrative and Global Oncology business strategy while continuously partnering… 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
- 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 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
- 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
- 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)
- …guidance to asset teams to enable seamless tumor-specific clinical development and strategy . Responsibilities - Accountable for developing the Global Clinical ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...and access and commercial business units to ensure unified Global Clinical Science Strategy .In conjunction with … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the implementation of the quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology ... open and effective communication and business partnering the cross-functional implementation of the Strategy , and Vision and Mission of Global RD/PV QA. Drive a… 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
