- Olympus Corporation of the Americas (Center Valley, PA)
- …with other functions both within and outside of Quality, including Regulatory Affairs , Information Technology, Service, Repair, Manufacturing, Commercial teams ... by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) more
- Merck (Upper Gwynedd, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more} **Preferred… more
- Merck (West Point, PA)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. . Apply domain knowledge ... Technology, Enterprise Architecture Management, Information Architectures, Life Science, Medical Affairs , Requirements Management, Strategic Management, Strategic Planning, System Designs… more
- 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
- 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
- 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
- Charles River Laboratories (Wayne, PA)
- …client visit and regulatory inspection find.ings. + Provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of ... of a variety of processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. In the… more
- Legrand NA (Canonsburg, PA)
- …accountability and excellence. + Cross-functional collaboration:Partner with Quality Assurance, Regulatory Affairs , and other departments to coordinate ... role ensures that all controlled documentation is accurate, accessible, compliant with regulatory standards, and aligned with company goals. As a key stakeholder,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… 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
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