- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Unknown (New Providence, NJ)
- …Categories Biotechnology Medical About the Role The Company is seeking a VP of Global Regulatory Affairs to lead the strategic and operational management ... Vice President, Global Regulatory Affairs About the Company Clinical-stage oncology biotech firm Industry Biotechnology Type Public Company Founded 2011… more
- Eisai, Inc (Nutley, NJ)
- …management of staff.Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... difference. If this is your profile, we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing regulatory … more
- Eisai, Inc (Philadelphia, PA)
- …strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and ... management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will...primary liaison between R&D functions, acting as the submission lead for designated global applications (eg, INDs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence… more
- Merck & Co. (North Wales, PA)
- Job Description Director Global Marketing Immunology - IBD Patient Strategy It is an exciting time to join our company's Immunology Team and our growing Global ... a key growth driver for our company. The Director, Global IBD Patient Strategy is responsible for shaping the...IBD patients in support of the launch of our lead asset in immunology. This role will develop a… more
- Merck & Co. (Rahway, NJ)
- …- Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate ... user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for...Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting… more
- Eisai, Inc (Bethesda, OH)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of... strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation… 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 & ... clinical, regulatory , formulation, commercial and other key our company functions. Lead the Device Development Engineering Core teams focused on development of… 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 ... areas centered around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... Then we would love to have you join us!Overview:The Director, Feasibility Lead , will drive the implementation of strategic, data-driven feasibility practices that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... RoleGenmab is currently seeking a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate, high profile, high impact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs, or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas ... global projects with high impact with ability to lead and project-manage cross-functionally and globally with business stakeholders is highly-preferredMust… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Merck & Co. (Rahway, NJ)
- …identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO ... regulatory , company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk… more
- Merck & Co. (North Wales, PA)
- …and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides biostatistical support ... for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and… more
