- Novo Nordisk (Plainsboro, NJ)
- …you ready to make a difference? The Position We are seeking a collaborative and science -driven global regulatory expert who wants to work with innovative ... Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro,...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 TAU ... within our Global Regulatory Affairs organization, based remotely. +...behaviors. **Minimum Requirements/Qualifications:** + Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred + Ideal candidate has… more
- Bristol Myers Squibb (Princeton, NJ)
- …through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute ... and Health Authorities. Develop & communicate strategic direction based on global regulatory guidelines and experience. **Position Responsibilities** In addition… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Sciences , Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and ... development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with...Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS team… more
- Ascendis Pharma (Princeton, NJ)
- …Medical Sciences team for the US business, the Medical Director handles deliverables and activities associated with management and implementation of phase ... Medical Director Do you want to be part of...Regulatory , Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to ensure… more
- Bristol Myers Squibb (Princeton, NJ)
- …through the testing and release process. + Supports clinical and commercial global regulatory filings and authors/ reviews/approves portions of the filings ... strategy and standards related to analytics. + Direct experience managing interactions with global regulatory agencies and in the preparation of regulatory … more
- Merck (Trenton, NJ)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...regulatory Chemistry, Manufacturing, and Controls (CMC) content for global submissions, ensuring adherence to international regulatory … more
- Taiho Oncology (Princeton, NJ)
- …of regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance ... Associate Director , Regulatory Affairs Strategy Princeton, NJ,...Performance Objectives: + Independently directs as well as prepares global regulatory affairs strategies and executes … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Sanofi Group (Bridgewater, NJ)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... **Job Title:** Medical Director - Global Medical Evidence Generation...needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a… more
- Norstella (Trenton, NJ)
- Sales Director , Regulatory Company: Citeline Location: Remote, United States Date Posted: Dec 20, 2024 Employment Type: Full Time Job ID: R-799 **Description** ... drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying on us to deliver...biotechnology and healthcare service providers, including the top 10 global pharma and CROs. Now, Citeline is proud to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Ascendis Pharma (Princeton, NJ)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director of Global Forecasting, US will be responsible for the generation, ... Oncology. Here at Ascendis, we pride ourselves on exceptional science , visionary leadership, and skilled and passionate colleagues. Guided...The Director will report into the Sr. Director of Global Forecasting and be heavily… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… 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 resolution. + ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...Participate in global product team meetings to provide US … more
- Ascendis Pharma (Princeton, NJ)
- …grow and develop their skills. We are seeking a highly skilled and experienced Senior Director of Global Forecasting to join our team Global Ascendis team. ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Associate Director , Global Oncology Corporate Communications **Location:** Cambridge, MA 50% remote working; limited travel expected. **About the ... needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a...world. Sanofi is looking for a proactive, high-energy Associate Director to join the Global Specialty Care… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director , Global Oncology Franchise Operations **Location** : Bridgewater, NJ or Cambridge, MA The Associate Director , Global ... of marketing, sales and operational roles + Demonstrated understanding of global pharmaceutical marketing strategies and regulatory /compliance environment +… more