- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to be a part of ... our Global Regulatory Affairs organization.In this role, you will work in close...a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Genmab (Plainsboro, NJ)
- …per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs , the key responsibilities include but ... an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… 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 ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleThe Associate Director of US Medical Affairs Solid Tumors Strategy will report to the Director , US Medical ... portfolio. The individual will support the development and execution of the US Medical Affairs strategy that is aligned with the company's goals and meets the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior Director , US ... lead the development and execution of the US Medical Affairs strategy that is aligned with the...healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross… more
- Merck & Co. (North Wales, PA)
- …promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product ... Job DescriptionReports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- Merck & Co. (North Wales, PA)
- …include, but are not limited to :Develops and executes US Medical Affairs strategy for Thoracic MalignanciesDrives creation and facilitation of training ... Job DescriptionThe Regional Director of Medical Affairs (RDMA) for...updatesInteracts with internal stakeholders for needs assessment and planning.Leads strategy and interactions with Patient Advocacy GroupsTracks guidelines and… more
