- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Formation Bio (New York, NY)
- …preventive actions (CAPA as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs , Clinical Operations) to ensure alignment on quality ... bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution… more
- Merck & Co. (Rahway, NJ)
- …of interest.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... (Executive Director ) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Bridgewater, NJ)
- …families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs (GRA)-Advertising and Promotion ... This role is responsible for overseeing several activities for Global A-P including but not limited to: + Lead...initiatives and associated cross-functional teams + Lead GRA A-P regulatory deliverables in support of technology evolution, and Gen… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...resolution. + Participate in global product team meetings to provide US … more
- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. Responsibilities: + Manages or represents Regulatory Affairs on the US promotional review committees for prescription ... Ad/Promo staff under the direction of the Executive Director , Regulatory Advertising & Promotion. + Provides...of market promotional and advertising strategies. + Updates the Regulatory Affairs advertising and promotion staff, review… more
- AbbVie (Branchburg, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and Promotion is ... 6 years of relevant industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred + Experience working in a… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- 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)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… 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 ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… more
- Bausch Health (Bridgewater, NJ)
- …helps lead the company in discussions with OPDP. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...our collective progress and impact. Responsibilities **:** + Provides regulatory review of advertising and promotional materials, new campaigns… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- City of New York (New York, NY)
- …Mayor's Office of Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the multidisciplinary External Affairs ... Director of OCMH and will directly manage 4 staff members.The Deputy Executive Director , External Affairs will work closely with the Executive Director … more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (nitric oxide) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... (Open) Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs plays a key… more
- Bristol Myers Squibb (Madison, NJ)
- …**Key Responsibilities** + Strategic and Tactical Planning: Responsible for the US Medical Affairs plans, in coordination with the Global Medical Affairs ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director… more
