- 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...within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising… more
- Genmab (Plainsboro, NJ)
- …authentic is essential 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...labeling strategy lead in development of the Company Core Data Sheep and US Prescribing Information. Responsible for maintenance… more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs ,...with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information depending on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.May serve as the single regulatory ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Genmab (Plainsboro, NJ)
- …patient information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , ... best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Mentor/instruct and provide guidance to… more
- Genmab (Plainsboro, NJ)
- …to be our best, and 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 Medical Affairs Solid Tumors Strategy...healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required A thorough understanding and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
