- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Legal Director (FDA promotion/ Labeling Drugs & Vaccines) The position provides legal support to the Human Health Division, ... with a focus on counseling clients in the areas of FDA promotion and labeling of drugs and vaccines.- The position also provides legal support to the Research… 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)
- …and positive interactions with colleagues. Essential Functions Therapeutic Area: Assist Manager/ Director in review of labeling for marketed products and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in… 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
- Aequor (Newbury Park, CA)
- …Business Partners as delineated in partnership/service agreements; maintains awareness of regulatory legislation pertaining to labeling and assesses and ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… 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
- Merck & Co. (Rahway, NJ)
- …on alliance global brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by ... Job DescriptionWe have an exciting Director opportunity to join our global oncology marketing team focusing on co-commercialization of an Antibody Drug Conjugate a… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel ... deliver omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing,… more
- AbbVie (Lake Bluff, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination ... guidelines, standards, etc. + Experience developing and implementing successful global regulatory labeling strategies. + Experience with InDesign a plus.… more
- Ascendis Pharma (Palo Alto, CA)
- 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
- 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: May 15, 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
- J&J Family of Companies (Horsham, PA)
- …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 -...regulatory guidelines and their applications for guidance for labeling . + Experience leading project teams within a matrix… more
- Bristol Myers Squibb (Princeton, NJ)
- …externally, contributing to cross-functional initiatives and identifies opportunities to influence regulatory policy and climate with respect to labeling content ... + Understands and interprets complex scientific issues as related to regulatory requirements and labeling strategy. Partners with key internal and external… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Legal Director (FDA promotion/ Labeling Drugs & Vaccines)** The position provides legal support to the Human ... with a focus on counseling clients in the areas of FDA promotion and labeling of drugs and vaccines. The position also provides legal support to the Research… 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
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... + Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develops solutions… more
