- 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 (New Brunswick, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and ... around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory ...and drives coordination of global and US … 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
- Merck (Rahway, NJ)
- …coaching/guidance to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... **Job Description** **R5 -** ** Director - Pharmacometrics,** **Quantitative Pharmacology and Pharmacometrics** _T_ _he (remote) position is only applicable for those… 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 (New Brunswick, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ICH guidance for clinical documents + Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key… 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
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...single vision as inspiring as Transforming patients' lives through science (TM) , every BMS employee plays an integral… 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
- TD Bank (New York, NY)
- …to ensure alignment with integrated remediation activities to our regulators. The Director - Regulatory Management and Remediation Office. This will involve: ... and your career, to new heights. Job Description: The TD Securities US Regulatory Management & Remediation team is responsible for the planning, execution and… more
- City of New York (New York, NY)
- …SKILLS: - Academic or professional background in engineering, chemistry, biological sciences , data sciences , environmental science , or environmental ... Job Description PROGRAM AND JOB DESCRIPTION: The Bureau of Environmental Sciences and Engineering (ESE) has about 100 staff that focuses on identifying and… 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
- 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