- Genmab (Plainsboro, NJ)
- … Affairs organization.In this role, you will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage development to ... PMCs, etc. Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal regulatory success. Represent US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization...that they own. Lead large-scale change initiatives across Global Regulatory Affairs and Clinical Safety and… more
- Genmab (Plainsboro, NJ)
- …time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include ... and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role,...working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... 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. (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
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report...programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development, approval and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the ... for cardiovascular diseases, 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)
- …a subject matter expert, providing advice and guidance on labeling to teams.As the regulatory labeling liaison on global Regulatory Affairs subteams, your ... in people and animals. In the capacity of a Global Labeling Lead , you will be instrumental...Labeling for assigned products, ensuring compliance with internal and regulatory standards.You will assist in the development and maintenance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and ... device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling… more
