- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Leads the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role offers ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate ... Director, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role will ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate ... Director of Regulatory Writing is a key role responsible for producing...key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is ... responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on assets which are subject to an Alliance. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsible for ... leading and developing global regulatory strategy for assigned development... strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Effectively liaise, ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Merck & Co. (Rockville, MD)
- …Regulatory organizations;Leadership for strategy and coordination of our Research & Development Division External Policy relationships to meet priorities;Building ... the company on the development and implementation of clinical research policy goals.Working closely with the Global Regulatory... research policy goals.Working closely with the Global Regulatory Policy team to align on clinical research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Lower Gwynedd, PA)
- …(AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed oncology medicines. Our company's ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control ... Job DescriptionOur Research Scientists are our Inventors. We identify and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr...has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently ... seeking a Regulatory Affairs Intern for summer 2025. This full-time position...position works for approximately 37.5 hours per week. Responsibilities:Support Regulatory Affairs Chemistry, Manufacturing, and Controls team with Investigational… more
- Merck & Co. (North Wales, PA)
- Job Description Director, Outcomes Research Vaccines Position Description Under the guidance of Executive Director, the incumbent has the primary responsibilities ... a worldwide basis and for planning and implementing Outcomes Research and Real World Evidence studies to meet the... plans for our Company products based on the regulatory , marketing and reimbursement environments on a worldwide basis,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
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