- Amgen (Thousand Oaks, CA)
- …pre-clinical toxicology approaches + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory ... range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one… more
- Sanofi Group (Morristown, NJ)
- …strategy and the network of collaborators from preclinical research to operational, regulatory , and commercial functions. Success in this role requires the ability ... of responsibility. The GPH will be responsible for interaction with regulatory authorities, approval of protocols, informed consent documents, clinical study… more
- Sanofi Group (Morristown, NJ)
- …for submission to regulatory agencies, including but not limited to the FDA and EMA + Prepare abstracts, posters and manuscripts for external presentation and/or ... potential drug-drug interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle… more
- Unither Pharmaceuticals (Rochester, NY)
- …made for improvement and to align processes to consistently manufacture quality products. Able to provide technical expertise for customer and government ... regulatory agency site inspections. Serves as a SME in...degree required. Minimum of ten (10) years in an FDA regulated microbiological function, preferably within a pharmaceutical/medical device… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …the overall medical strategy taking into consideration the medical, scientific, regulatory and commercial issues and opportunities for assigned portfolio products. ... team evaluating submitted proposals. + Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling… more
- Sutter Health (Fairfield, CA)
- …Ensure compliance with accreditation standards (eg, URAC, ACHC); collaborate with the quality assurance team on documentation. + **Cold Chain Packaging & Shipping:** ... involves a fast-paced environment with an emphasis on compliance and regulatory standards in patient care and medication management. **PHARMACY SERVICES** Assists… more
- University of Southern California (Los Angeles, CA)
- …internal and external audits, batch record review, and deviation investigations to uphold regulatory and quality standards. + Assists in training operators and ... to troubleshoot and resolve technical issues in a timely manner. Knowledge of regulatory requirements and guidelines (eg, FDA , EMA) related to cGMP. Preferred… more
- Sutter Health (Oakland, CA)
- …compliance with accreditation standards (eg, URAC, ACHC); collaborate with the quality assurance team on documentation. Cold Chain Packaging & Shipping: Manage ... frequent interaction with patients and healthcare professionals; adherence to regulatory standards. **Job Description** : PHARMACY SERVICES. + Responsible for… more
- Stryker (Portage, MI)
- …reusable and single use medical devices.** + Collaborate closely with R&D, Quality , Manufacturing, Regulatory , Clinical, Marketing and Project Management to ... + Develop and implement compliant testing protocols and guidelines to support regulatory submissions for new and existing medical devices. + Coordinate and deliver… more
- OhioHealth (Pickerington, OH)
- …to assure maximum standardization of practices across the system; Ensures compliance with regulatory agencies including FDA , CAP, CLIA, TJC, OSHA, CMS; 10% ... compliance with hospital policy and with state, federal and other regulatory agencies. This position establishes and maintains interdepartmental communication with… more