- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible for ... to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory ...will allow for seamless submission planning processes from a Global perspective. The Associate Director liases with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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
- Genmab (Princeton, NJ)
- …Role The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group ... within Regulatory Affairs (RA) to ensure timely and high-quality document...biologics and drug submissions according to FDA and other global health authorities. Lead the Templates Board… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a satisfactory regulatory compliance level for these organizations for local and global markets. Liaises with regulatory agencies as needed and internally on ... with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory...and advise the GMP road map to meet changing regulatory and business needs. Lead remediation and risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation and ... clinical development plans, and commercialization plans and other critical documents.Responsibilities- Lead the preparation of global value dossiers which… more
- Merck & Co. (Rahway, NJ)
- …, Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for Women's ... commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized… more
- Merck & Co. (Rahway, NJ)
- …in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the late ... organization. This role provides a unique opportunity to serve as a GBL ( global brand lead ) and gain unique and valuable experience.Specific Responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry ... set the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the generation, integration ... and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management responsibility… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Eisai, Inc (Nutley, NJ)
- …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, ... regulatory , and compliance standards. Collaborating with business and EIT...Privacy standards through continual risk and security assessment.Collaborates with global stakeholders from EIT and leaders across regions in… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… more
- Genmab (Yardley, PA)
- …project deliverables while adhering to regulatory requirements for programs and products. Lead the Global Regulatory Team (GRT) and Submission Team(s). ... and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this...our hybrid policy. This position will report to the Regulatory Strategy Team Lead . Responsibilities: The key… more
- Genmab (Woodbridge, NJ)
- …be responsible for the development, implementation, and maintenance of US/ global regulatory strategies across all stages of development. Lead , manage and ... and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this...with US FDA for assigned projects. The US/GRL will lead and/or participate in meetings with FDA and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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. (North Wales, PA)
- Job DescriptionThe Scientific Strategy lead plays a critical role in the launch of our adult pneumococcal vaccine, a critical growth driver for the organization and ... priority, amidst a highly competitive and dynamic market. The Scientific Strategy Lead w ill be responsible for developing the strategies and relevant initiatives… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Merck & Co. (North Wales, PA)
- …in patients who need it most. Invent. Impact. Inspire.Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and ... you to play:-Campaign Development LeadPut marketing strategy into action as you lead the development of our customer experience and campaign planning. Leveraging… more
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