- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and...resolution.Participate in global product team meetings to provide US regulatory support… more
- Genmab (Plainsboro, NJ)
- …can work remotely 40% of the time. You will report to the Global Regulatory Strategy Team Lead .ResponsibilitiesThe responsibilities of the role will include, ... you will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage...on US procedural and documentation requirements to the Global Regulatory Team and cross-functional teams to ensure… more
- Genmab (Plainsboro, NJ)
- …requires onsite presence 60% of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory ... regulatory requirements for programs and products. Participate in regulatory sub- team , clinical management team ,...they are implemented, if applicable Collaborate with the Labeling Team Lead to develop Company Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by GPT and other governance bodies.Serve as a leader of the GRT (Global Regulatory Team )The primary point of contact with Alliance Partners Joint-RA teams and ... of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 serve as an...serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives Lead a team of Role-Specific Training Support Partners to ensure ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...integral member of the CMR Strategic Operations (SO) Leadership Team and will be responsible for leading the strategy,… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …into Omnichannel capabilities across various customer segments within the given TA Leadership & Team Management: Lead and develop a team of Experience ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...Position The purpose of the Omnichannel Orchestration Therapeutic Area Lead is to develop and implement a comprehensive strategy… more
- Merck & Co. (Rahway, NJ)
- …development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief ... in? Are you ready to experiment with us? The Position The Integrated TA Lead is instrumental in shaping and executing NNI's strategic initiatives within the TA. This… more
