- Leica Biosystems (Miami, FL)
- …PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners to develop ... about the Danaher Business System which makes everything possible.The Senior Principal , Regulatory Affairs is responsible for regulatory strategy… more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for planning/managing real world ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionThe Director ( Principal Scientist) has primary responsibility for the planning...Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting,… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or… more
- Cytokinetics (South San Francisco, CA)
- …Job purpose Cytokinetics is seeking an experienced and highly motivated Senior Director, Regulatory Affairs to join the Global Regulatory Affairs ... requirements and industry standards are met. The Senior Director, Regulatory Affairs will lead the Global ...marketing applications, and their amendments in conformance with local regulatory requirements Serves as a principal interface… more
- BioSpace (New York, NY)
- …within the organization. Cross-functional Collaboration: Work closely with clinical development, regulatory affairs , market access, and commercial teams to align ... platforms alongside our Chief Scientific Operations Officer, Senior Director, and Lead Principal Scientist. Define a Medical Affairs organization in conjunction… more
- Cytel (Cambridge, MA)
- …with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs , to develop and implement appropriate statistical ... analyzing complex manufacturing data to ensure product quality, consistency, and regulatory compliance. Responsibilities As a Principal Biostatistician, your… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …in the PC space Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external ... after clinical proof-of-concept studies, including but not limited to regulatory submissions and life-cycle management. Translational disease strategies in… more
- Syneos Health Careers (Morrisville, NC)
- …built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. ... the trial are conducted efficiently and effectively Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations… more
- The University of Pennsylvania (Philadelphia, PA)
- …management of laboratory tool, documentations, and processes to ensure regulatory compliance and timely completion of project/program deliverables. Closely ... with Senior Research Specialists, Postdoctoral Fellows, Graduate Students and Principal Investigator (PI) on experimental/clinical work set ups in accordance… more
- University of Kansas Medical Center (Kansas City, KS)
- …research (CFR, GCP, HIPAA). Experience with statutes and guidelines relevant to regulatory affairs in clinical research. Experience study budgets, contracts, and ... class research. Job Description: Job Duties: Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential… more
- Veterans Health Administration (Tucson, AZ)
- …are in the design phase for a new subspeciality building. SAVACHS is the principal teaching affiliate of the University of Arizona Colleges of Medicine, Nursing, and ... ACLS certification. A commitment to compliance with VA and SAVAHCS regulatory requirements is expected. Some administrative experience is preferred. Investigators… more
- Danaher Corporation (Boston, MA)
- …PMA in USA) and will mentor the organization in these key activities. The Senior Principal Regulatory Affairs will work with Biopharma partners to develop ... Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal , Regulatory Affairs is responsible… more
- Abbott (Plymouth, MN)
- …and get on with their lives. **The Opportunity** We are seeking a ** Principal Regulatory Affairs Specialist** to join Abbott's Electrophysiology Division ... Plymouth, MN or St. Paul, MN. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory… more
- NextEra Energy (Houston, TX)
- ** Principal Regulatory Affairs Analyst** **Date:** Jul 11, 2025 **Location(s):** Houston, TX, US, 77002 **Company:** NextEra Energy **Requisition ID:** 88162 ... today. **Position Specific Description** At NextEra Energy, we are taking our Principal Regulatory Affairs role to the next level. These talented employees… more
