- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820,… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulated systems in the pharmaceutical or biotech industries, preferably in a regulatory affairs , clinical, medical affairs , or pharmacovigilance domain. ... (RSBO) Strategy and Execution Associate Director with a focus on the Regulatory pillar is responsible for leading and supporting regulated Organon Research &… more
- Merck (Upper Gwynedd, PA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- J&J Family of Companies (Spring House, PA)
- …partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs , clinical pharmacology, health economics, and the disease ... for assigned compound through close partnership with the compound global medical affairs leader. + Serves as the clinical leader for product evaluation and… more
- UPMC (Williamsport, PA)
- …This full-time position involves managing clinical operations, quality management, regulatory affairs , continuing education, and fiscal responsibilities. The ... programs. + Seek approval for Continuing Education Credits and maintain CE records. Regulatory Affairs Management + Coordinate regulatory compliance… more
- J&J Family of Companies (West Chester, PA)
- …as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs + Responsible for communicating business related issues or ... ensure document accuracy and compliance with local procedures, J&J guidelines and regulatory requirements. + Managing daily activities to ensure timelines are met. +… more
- Merck (Upper Gwynedd, PA)
- …immunology, neurology, cardiometabolic and others as needed by the pipeline. + Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Pfizer (Collegeville, PA)
- …Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs \#LI-PFE ... Labeling Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory , and Commercial + Drive global labeling strategy through development… more
- University of Pennsylvania (Philadelphia, PA)
- …regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality ... the year. This allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with family-whatever your personal needs… more