- Merck (North Wales, PA)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively… more
- University of Washington (Seattle, WA)
- …The Assistant to the Director reports to the Director of Clinical Regulatory Affairs and provides administrative support and back-up support to ... up to three directors in the Clinical Regulatory Affairs Unit /General...regulatory and policy compliance. The Assistant to the Director exercises independent judgment and discretion in handling confidential,… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...precedent + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),...and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Leader (General ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products...components + Lead the planning and implementation of global regulatory filings (eg clinical trial applications, marketing… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... 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)
- …help create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and ... overseeing data governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset for regulatory … more
- Lilly (Indianapolis, IN)
- …phase (first in human, Ph1/Ph2) submission experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including ... to evolve how Lilly and LRL operates. The **Senior Director ** is responsible for managing all Regulatory ...college or university + At least 5 years of regulatory affairs experience with research-based drug development,… 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
- Sumitomo Pharma (Springfield, IL)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality ... the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and executing large scale… more
- Novo Nordisk (Plainsboro, 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
- Danaher Corporation (Fargo, ND)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...+ Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial… more
- BeiGene (Emeryville, CA)
- The Executive Director of Regulatory Affairs , Companion Diagnostics (CDx) will be responsible for developing, advising on and executing global regulatory ... across programs. + Support the integration of CDx into clinical trials, ensuring all regulatory aspects are...**Qualifications:** + Bachelor's, Master's, or PhD in Life Sciences, Regulatory Affairs , or a related field. … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …will provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a ... and multicultural environment and leverages their extensive experience to represent regulatory affairs in discussions with external and internal stakeholders.… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Independently ... Regulatory , Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.… more
- AbbVie (South San Francisco, CA)
- …technologies to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing regulatory ... sub-teams + Develop and implement competitive and effective global regulatory strategies for oncology products including clinical ,...preferred. + 8 - 12 years of experience in Regulatory Affairs (strong preference for experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The 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 will include… more
- BeiGene (Emeryville, CA)
- …met while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the solid tumor ... The Executive Director , Solid Tumor North America Lead will be...on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical… more
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