- ThermoFisher Scientific (Pittsburgh, PA)
- …with compliance audits, both internal and external. + Prepare various regulatory compliance reports for submission to government agencies as applicable. + ... Board of Pharmacy licenses and applicable accreditations. + Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.… more
- Merck (North Wales, PA)
- …and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and ... Skills:** Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical … more
- University of Pennsylvania (Philadelphia, PA)
- …of study specific case report forms, as well as, to provide direct regulatory / compliance guidance. + Perform additional regulatory duties as assigned. ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical Research Regulatory Specialist… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Pfizer (Collegeville, PA)
- …responsible for developing and executing global (Influenza/COVID-19) and US (COVID-19) regulatory strategies and ensuring compliance with applicable regulations. ... Regulatory and Cross-functional teams, managing submissions, and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19).… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …Management:** Establish and maintain data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (eg, FDA , EMA) and ... **Global Systems:** Manage and optimize global Quality systems to ensure compliance , efficiency, and continuous improvement. Establish and maintain best practices… more
- ThermoFisher Scientific (Allentown, PA)
- …products and make Quality a competitive advantage by achieving outstanding GMP regulatory compliance with zero patient impacting events and drive quality ... regulatory expectations. **Key responsibilities:** Support the established Quality Compliance strategy. Work to ensure continuous improvements regarding the most… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Process returns adhering to company policies, procedures, and documentation requirements + Maintain FDA and DEA regulatory compliance by ensuring cleanroom ... experience preferred + Technical capacity with Excel and Outlook + Pharmaceutical Regulatory statues, GMP compliance + Previous Distribution, Inventory Control,… more
- Guthrie (Sayre, PA)
- …has broad oversight responsibilities across core domains: + Clinical Research Operations in compliance and in regulatory areas. + Supports research and scholarly ... of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH,... Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). +… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …to ensure compliance with pharmaceutical traceability and labeling standards + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity ... quality checks to ensure shipment integrity, proper labeling, and compliance . + Generate and verify shipping documentation such as...Time Management + Familiarity with DEA, DSCSA, and cGMP compliance + Experience with RF technology + Experience in… more