- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and maintain correspondence relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with ... compiling, publishing and submission of regulatory dossiers. The Director of Regulatory Affairs will participate in discussions on change controls,… 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... Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory … 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 ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...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...to support successful IND and (s)BLA submissions. Evaluate various regulatory mechanisms that allow optimization of product … 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 ... of the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities… more
- Merck & Co. (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director of US Medical Affairs Solid Tumors Strategy will report to the ... Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will assist the strategy lead to providing medical affairs leadership on ovarian cancer and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory ...on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an… 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
- 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
