- Insmed Incorporated (Bridgewater, NJ)
- …with Regulatory project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for creating (and/or updating) ... to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed marketed and to-be-marketed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around 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 position may serve as an ad hoc member of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and… more
- Merck & Co. (Rahway, NJ)
- …input on such activities as: target product profile development, global regulatory filing strategy, labeling , launch readiness reviews, organized customer ... Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …will provide strategic input and operational leadership and management oversight of regulatory labeling across Gilead's product portfolio. You will oversee or ... in prescription drug labeling . Extensive experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around 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 position may serve as an ad hoc member of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …consistency with product labeling and with all applicable regulations. TheSenior Director , Commercial Regulatory Affairs will stay abreast of changes in the ... on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and… more
- Bausch Health (Bridgewater, NJ)
- …in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are ... at FDA's Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact… more
- Bausch Health (Bridgewater, NJ)
- …reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC...leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The successful candidate will lead a group of Global Regulatory Leads (GRLs), who are responsible for development and implementation of world-wide ... regulatory strategies for their assigned projects. This may include...of development through registration and mature products. The Executive Director could also support business development due diligence activities.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...+ With support of Commercial RA, develops initial product labeling and assesses proposed product claim proposal (pre-NDA). +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will develop and ... execute Precision Medicine regulatory strategies in alignment with the drug global ...IDEs, SRDs, PMAs, device clinical performance study applications and labeling for drug and diagnostic products. + Manage internal… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy within a development team (DT). + Serve as ... of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to ... Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance....Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and cross-functional team… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Responsibilities** + Ensure global regulatory plans support a precision medicine approach eg integrated drug/diagnostic ... regulatory and submission plans), including HA engagement plans and...study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life ... + Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities +...+ Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes… more
