- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... the conduct of audits by study sponsors, CROs, the FDA , and other entities as required. + Process and...CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with… more
- University of Pennsylvania (Philadelphia, PA)
- …and process, with minimal supervision , all initial oversight submissions for regulatory documentation through the IRB, FDA and all applicable institutional ... (CROs), and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up Specialist is… more
- Merck (West Point, PA)
- …manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out, ... testing. + ** Regulatory Compliance ** : + Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global … more
- Sumitomo Pharma (Harrisburg, PA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,...clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more
- West Pharmaceutical Services (Exton, PA)
- …**Job Summary** The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, ... and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system… more
- University of Pennsylvania (Philadelphia, PA)
- …communication with sponsors, investigators, and cross-functional research teams (including regulatory and data management teams), ensuring protocol compliance ... communication with research team, including Investigators, project managers, CRC and regulatory team, to ensure patient safety and proper study conduct. Participate… more
- Globus Medical, Inc. (Audubon, PA)
- …in full compliance with Globus quality system and other applicable regulatory bodies . Designs and develops instruments and implants using Creo and SolidWorks ... and market plans . Assists in the writing of regulatory applications to the FDA and other...MedTech Code, and all other company policies. . Ensures Compliance with applicable governmental laws, rules, and regulations, both… more
- Globus Medical, Inc. (Audubon, PA)
- …in full compliance with Globus quality system and other applicable regulatory bodies + Designs and develops instruments and implants using Creo and SolidWorks ... and market plans + Assists in the writing of regulatory applications to the FDA and other...MedTech Code, and all other company policies. + Ensures Compliance with applicable governmental laws, rules, and regulations, both… more
- PCI Pharma Services (Philadelphia, PA)
- …+ Foster a culture of quality awareness, continuous improvement, and regulatory compliance **Qualifications:** The requirements listed below are representative ... overseeing and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role… more
- Primo Brands (Ephrata, PA)
- …raw source water, water processing and finished bottled water products to ensure regulatory compliance with the applicable Food and Drug Administration ( FDA ... plant quality assurance programs to ensure adherence to established FDA , State, local, IBWA and PWNA standards. + Contribute...a member of the Food Safety team to ensure compliance with all applicable bottled water and beverage safety… more