- 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)
- …labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory labeling point of ... Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible... documents that meet quality and compliance standards and regulatory labeling requirements to support timely … more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Team (GRT) Product Development Team (PDT), Early Development Team (EDT),-and Labeling Working Groups).--Participate in regulatory due diligence activities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... on regulatory strategy documents Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with… 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
- 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
- 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
- Teva Pharmaceuticals (West Chester, PA)
- …process development, device development, analytical methods, formulation development, manufacturing, and labeling . The Sr Director , Regulatory Affairs CMC ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Takeda Pharmaceuticals (Columbus, OH)
- …labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met for assigned products. **How you will ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will...regulatory requirements. You will serve as the regulatory expert for … more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- J&J Family of Companies (Titusville, 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
- Merck (Rahway, NJ)
- …teams while ensuring compliance with applicable regulatory requirements + Serving as regulatory labeling point of contact on global Regulatory Affairs ... Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible... documents that meet quality and compliance standards and regulatory labeling requirements to support timely … 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 (Cambridge, MA)
- **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
