- 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
- 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
- Insmed Incorporated (NJ)
- …you'll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under ... operational execution, while supporting cross-functional teams to ensure alignment with global regulatory requirements and internal standards.What You'll Do:… 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
- Larimar Therapeutics (Philadelphia, PA)
- …Works closely with RA Sr. Director and serve as backup to other global regulatory activities Strategy, Guidance Responsible for defining, developing and ... efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing and quality… more
- Eisai, Inc (Boston, MA)
- …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
- Eisai, Inc (Durham, NC)
- …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
- Unknown (Boston, MA)
- …to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations and guidelines ... for pharmaceutical products. They will have a deep understanding of global regulatory requirements and a track record of successful interactions with Health… 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
- 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
- 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 ... around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Medical Affairs, Medical Analytics will be responsible for managing… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo- lead the implementation of the… 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
- 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
- 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
- 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
- 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
- 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
- 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
- Insmed Incorporated (NJ)
- …from regulatory authorities on safety issues for assigned products and lead the integrated safety input into all regulatory documents where required.Maintain ... to regulatory authorities, health authorities, or at conventions, meetings, etc. Global Pharmacovigilance experience, including robust knowledge of global PV… more
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