- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical , may be called upon to guide a team ... facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with cross-functional project… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Summary/Description: Under the guidance of the Assistant Director , Regulatory Affairs & Quality Assurance, the Clinical Research Regulatory Manager ... oversees operations for the UNC Lineberger ( LCCC ) Clinical Protocol Office ( CPO ). Serves as a...leadership team with a primary focus on management of regulatory personnel, operational and strategic planning, and implementation of… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical ... USA501 Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs ...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more
- Amgen (Los Angeles, CA)
- …science that can turn the tide of serious, life-interrupting illnesses. **Executive Director of Regulatory Affairs ** **Live** **What you will ... change the world. In this vital role as Executive Director of Regulatory Affairs , you...oral and written + Ability to understand and communicate scientific/ clinical information + Comprehensive understanding of regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Friday, June 28, 2024 Looking for a chance to make a ... assigned to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead...development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs… more
- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical , non- ... and regulatory colleagues . Contributes to the development of global clinical regulatory plans and strategies; identifies and proposes risk mitigation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development.… more
- J&J Family of Companies (Cincinnati, OH)
- Associate Director , Regulatory Affairs (Instruments & Accessories) - Robotics & Digital Solutions, Inc. - 2406195848W **Description** Robotics & Digital ... Johnson family of companies, is recruiting for an **Associate Director , Regulatory Affairs ** to support...management specialists, to ensure clinical research and clinical evaluation are performed in accordance with regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for ... by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development.… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...+ Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and...clinical studies. You will provide operational and technical regulatory assistance through all stages of clinical … more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... format and information in the development and execution of regulatory submissions. + Ensures accuracy of Clinical ...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...Provide guidance for resource and development planning + Approve regulatory filing strategies based upon proposed preclinical, clinical… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- The Director of Clinical Affairs Program Management leads and coordinates program management activities for clinical projects and/or clinical ... Director will work with the representatives from Clinical Affairs functional teams (Site Operations, Lab...Lab Operations, Data Management) to ensure timely deliverables to Regulatory Affairs or other stakeholders. This role… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department...positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising… more
- J&J Family of Companies (Horsham, PA)
- …Johnson & Johnson is currently seeking an Associate Director , Clinical Scientist to join our world-class Medical Affairs Gastroenterology Therapeutic ... Associate Director , Clinical Scientist- Gastroenterology Therapeutic Area...In this role, you will contribute to world-class Medical Affairs sponsored and supported clinical programs for… more
- Danaher Corporation (New Brighton, MN)
- …lives with diagnostic tools that address the world's biggest health challenges. The US Clinical Affairs Director for Radiometer Acute Care Dx is responsible ... US-based Hub will play a major role in the clinical program supporting EU and US regulatory ...in Minneapolis. This position will report to the Sr. Director Clinical & Medical Affairs … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... vaccine programs in various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, … more