- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD or DO ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Medical Director serves as the subject matter expert for our… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality… 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
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating… 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
- J&J Family of Companies (Raritan, NJ)
- …Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling ... Associate Director , Global Labeling Product Leader (1...regulatory guidelines and their applications for guidance for labeling . + Experience leading project teams within a matrix… 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: 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
- Novo Nordisk (Princeton, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… 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 (Princeton, 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
