- 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 ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… 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,...their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference… more
- Globus Medical, Inc. (Audubon, PA)
- …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Globus Medical, Inc. (Audubon, PA)
- …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… 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 ... NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected… 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …(eg, clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… 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 expertise in leading regulatory filings across… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development,… more
- University of Pennsylvania (Philadelphia, PA)
- …The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical Research Regulatory Specialist… more