- Novo Nordisk Inc. (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Merck & Co. (Rahway, NJ)
- …labeling and obtain shortest time to approval by regulatory agencies.Functions as global regulatory lead assigned to programs where the compound is ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory...of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product… more
- Merck & Co. (Rahway, NJ)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary,...delivery of targeted product labelingProvide expert advice as the Global Regulatory Lead to Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also interacts with other therapeutic area leaders and joint Alliance partners.Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the ... regulatory / non- regulatory change review and change management process.Team Leadership: Lead the global teams in the execution of Risk and Compliance… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …Description of Position- This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... Switzerland, Canada, Japan, Australia and BrazilStay abreast of evolving global regulatory landscapes for medical device and...analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and … more
- Merck & Co. (Rahway, NJ)
- …Global Oncology Marketing for Lung cancer for our Company's oncology business.- The Global Marketing Director will lead strategies and marketing efforts ... in Rahway, NJ and will report to the Executive Director , Global Marketing for NSCLC.The position will...leader engagements, medical symposia, webcasts, and speaker forumsLung Disease lead for the evolution of the organization's Early Detection… more
- Merck & Co. (Rahway, NJ)
- …keeping up with the latest regulatory guidelines and trends.Collaborate with global regulatory teams to align strategies and ensure submission readiness in ... Job DescriptionThe Executive Director , Device Quality & Regulatory will...regulatory Chemistry, Manufacturing, and Controls (CMC) content for global submissions, ensuring adherence to international regulatory … more
- Daiichi Sankyo, Inc. (Bernards, 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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Merck & Co. (Rahway, NJ)
- …Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us ... technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate...while developing and expanding your career.-- As GxP Strategic Lead , you will be part of a team that… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA ... 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 DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Our company is seeking a highly motivated candidate for the position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead / Director /Senior Director - Safety ... Safety Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... research relevant duties under the RDPV QA functionMust have proven ability to lead and influence others within a global /matrix environment in the pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …Molecule Global Science, Engineering, & Commercialization (SM GSEC) The Director , DCT Leadership position in the Manufacturing Division is a dedicated full-time ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
