- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… 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
- 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
- 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
- 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
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... CMC issues. With regard to these matters, the Senior Director will provide strategic as well as regulatory... Director will provide strategic as well as regulatory leadership on the project teams. Regeneron has a… more
- BlackRock (New York, NY)
- …retirement, energy security, financial technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government ... policymakers around the world on financial markets policy. Since 2009, the Government Affairs & Public Policy team has steadily established the firm as a respected… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate 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… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs , Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs , Global Patient Safety,… 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
- 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
- System One (Florham Park, NJ)
- …hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director ) in developing and executing ... Job Title: Director , US Regulatory Affairs ...intelligence to provide background insights. Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
