- AbbVie (Irvine, CA)
- …for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface with… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from ... the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- NextEra Energy (San Francisco, CA)
- **Senior Director , Regulatory Affairs (West)**...the Senior Director - Regulatory Affairs will lead NextEra's regulatory strategy ... **Employee Group:** Exempt **Employee Type:** Full Time **Job Category:** Legal/ Regulatory /External Affairs **Organization:** NextEra Energy Project Management,… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST… more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs - Corporate Category: Legal Position Type: Regular Full-Time External ID: 14913 Location: Torrance, CA, United States ... for multiple complex projects led by the corporate regulatory affairs team, including process improvement for...other regional regulatory directors in shaping cohesive regulatory strategy and ensuring effective integration of… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products... Affairs department + To develop a comprehensive regulatory strategy that takes into account worldwide… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...GRTs within Amgen's GRAAS organization, + Develop a comprehensive regulatory strategy that takes into account worldwide… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and..., Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the… more
- Gilead Sciences, Inc. (Washington, DC)
- …of where they live or their economic status. ** Director , Therapeutic Area Strategy - Virology, Government Affairs ** This newly created position will support ... third-party and think tank engagement, public policy and messaging development. The Director , Therapeutic Area Strategy - Virology will support the development… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...and is responsible for ensuring the execution of regional regulatory strategy in line with the global… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Boehringer Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to ... to the continuous improvement of processes and standards within Regulatory Affairs . If you have a strong...in international cross functional project teams, proactively define global regulatory submission strategy for the development of… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Lilly (Indianapolis, IN)
- … Director /Executive Director ** is responsible for managing all Regulatory activities ( strategy and implementation) for assigned programs across different ... decision-making related to molecule development. + Consult on global regulatory strategy , advise on IND/CTA content including...college or university + At least 7 years of regulatory affairs experience with research-based drug development,… more
- Sumitomo Pharma (Columbus, OH)
- …be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . The job is responsible for strategic direction ... activities and budget within SMPA and with alliance partners. + Oversee the strategy and development of Medical Affairs plans and scientific platforms for… more
- Sumitomo Pharma (Columbus, OH)
- …be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . The job is responsible for strategic direction ... to fight infections. The role will provide set Medical Strategy for both internal company programs and external facing...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
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