- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) ... global health authority query (HAQ) tracker and archiving regulatory correspondencesSupport DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and… more
- Merck & Co. (Rahway, NJ)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... projects and teams as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to global… more
- 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)
- …The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Merck & Co. (North Wales, PA)
- …and Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical ... acquisition (M&A) projects.This role will lead collaboration efforts, support and lead global projects in relation to:QUALITY & COMPLIANCE ACROSS GLOBAL… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … education and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... member of the Global Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL), and other… more
- Merck & Co. (North Wales, PA)
- …and requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs, GCTO and others to implement the regulatory ... sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to...willing to learn and grow their knowledge in the global regulatory requirements landscape for Drugs, Digital… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions to ensure SMTs are performing according to necessary ICH/GCP-relevant regulatory requirements and global , departmental and geographical SOPs, policies ... 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)
- … Safety Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external) based on the submission schedule.Oversees the planning of all Global complex regulatory submissions (NDAs, INDs, BLAs, MAAs, and supplements). ... within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Lead a cross-functional team within DSPD RD to… 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
- Merck & Co. (Rahway, NJ)
- …The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory and Clinical Safety- Operations Process and Systems-(GRACS-OPS) ... sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to...is responsible for the execution of regulatory strategy to get and keep products on the… 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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug ... for regulatory submissions and associated messagingWork closely with regulatory CMC lead and overall development team to insure overall regulatory … more
- DivIHN Integration Inc (Green Oaks, IL)
- …of products by preparing documentation needed for registration in EURI/MENAP global . Individual shall develop partnership with other regulatory functions, ... 847 1027 Divya at 224 369 2969 Title: Specialist Regulatory Affairs, EURI/ MENAP Location: Abbott Park, IL Duration:...and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
- Merck & Co. (Rahway, NJ)
- …commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized ... Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for Women's cancer… 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
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