- University of Pennsylvania (Philadelphia, PA)
- …all initial oversight submissions for regulatory documentation through the IRB, FDA and all applicable institutional regulatory review committees. In collaboration ... for NIH, pharmaceutical companies, contract research organizations (CROs), and the FDA , as well as, organize and maintain all regulatory affairs documentation/files… more
- University of Pennsylvania (Philadelphia, PA)
- …prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing ... pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files… more
- Fujifilm (Harrisburg, PA)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …daily comprehensive regulatory reviews of new products. + Ensure product compliance with applicable federal, state, and international regulations, including 21 CFR ... + Organize and validate device data for submission and registration with the FDA GUDID database. + Assist with customer order approvals, including medical devices… more
- MTF (Olyphant, PA)
- …materials for shipment to contract sterilizer. Maintain MTF's quality assurance standards and compliance with ISO, AATB, TGA and FDA regulations. Maintain raw ... performed meets MTF's quality assurance standards and is in compliance with ISO, AATB, TGA and FDA ...in compliance with ISO, AATB, TGA and FDA regulations. 7. Execute transactions in QAD to ensure… more
- WellSpan Health (York, PA)
- …and some evenings **General Summary** Coordinates clinical research activities and compliance to study requirements, and patient and staff considerations relative to ... study requirements. + Assists investigators in evaluating the quality of care and compliance to protocol requirements. Follows by ensuring compliance with all… more
- Merck (North Wales, PA)
- …seamless communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the ... with global regulatory authorities to ensure successful registration and compliance . **Primary Responsibilities** + Develop and lead global regulatory strategies… more
- CSL Plasma (Philadelphia, PA)
- …facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies. ... Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all...include, but not limited to: ADA, Civil Rights, EEOC, FDA , GHA, HIPAA, and OSHA. + Maintain confidentiality of… more
- Philips (New Kensington, PA)
- …oversee regulatory inquiry responses, and reviews these responses to ensure compliance with C&R standards. + Leads meetings with senior internal/external ... standards to proficiently execute correction and removal tasks, ensuring compliance and swift resolution of issues to uphold product...You've acquired a minimum of 8+ years' experience in FDA Regulated Post Market Surveillance (PMS), with a focus… more
- Sumitomo Pharma (Harrisburg, PA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy… more