- 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 ... be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling , Policy and Intelligence. The position will be based in our Princeton, New… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune 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...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions… more
- Genmab (Plainsboro, NJ)
- …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 ... success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and...FDA meetings as relevant. Support global regulatory lead and labeling strategy lead in development of the Company Core… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... manufacturing scale up, equipment and process qualification, packaging and labeling . This position will interface with Operations, Regulatory, Quality Assurance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Genmab (Plainsboro, NJ)
- …programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for the assigned projects Lead ... plans) and ensure that they are implemented, if applicable Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information… more
