- J&J Family of Companies (Horsham, PA)
- …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the enhanced… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and… more
- Organon & Co. (Plymouth Meeting, PA)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...with the FDA , EMA, or other EU regulatory agencies, including telephone calls and e-mail; chair meetings… more
- University of Pennsylvania (Philadelphia, PA)
- … Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable ... resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title...FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory … more
- System One (Malvern, PA)
- …meetings, adverse event review and reporting globally. + Perform duties as the main Regulatory Contact for FDA , Person Responsible for Regulatory Compliance, ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type:...marked surveillance monitoring and reporting activities, including those for FDA and EU MDR. + Strong organizational skills, self-directed,… more
- Sumitomo Pharma (Harrisburg, PA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Merck (North Wales, PA)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... + Experience leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated success in managing regulatory filings across… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …+ Comprehensive knowledge of two or more GXPs, in-depth knowledge of EU and US FDA regulatory standards, knowledge of regulatory standards in other counties ... and Regulatory Affairs for arranging more information/ samples from FDA . + Managing Quality Management Review meetings, circulating minutes of meeting,… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assists in the writing of regulatory applications to the FDA and other regulatory bodies + Partners ... design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The… more