- University of Pennsylvania (Philadelphia, PA)
- …Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, initial ... responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute to Informed Consent… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and maintain data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (eg, FDA , EMA) and industry standards (eg, GxP, ... - Advanced analytic skills, and general understanding of the drug development and regulatory process. - Successful track record of leadership and timely… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Deviations, CAPA, Change Control related to QA and warehouse operations + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Ensure US Allentown ... area + Handling of destruction of non-controlled products and controlled substance drug products. + Handling of Quality Inspection of all incoming batches per… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …product. + Handling of destruction of pharmaceuticals drug products. + Support regulatory inspections ( FDA , DEA, VAWD/NABP, NJDOH etc.) + Ensure US Allentown ... Warehouse activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency with applicable… more
- Charles River Laboratories (Horsham, PA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and… more
- Charles River Laboratories (Horsham, PA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and… more
- Charles River Laboratories (Wayne, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- GE HealthCare (State College, PA)
- …+ Experience with medical device manufacturing or ultrasound technology. + Familiarity with regulatory standards such as ISO and FDA . + Project management ... quality, planning, purchasing and operations teams to ensure compliance with regulatory standards. + Leverage data to identify and implement process improvements… more
- Teleflex (Wayne, PA)
- …and support to clinical end-users, clinical sales specialists, sales team, Regulatory , Engineering, marketing, and other corporate departments on safe and effective ... requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more