- Boehringer Ingelheim (Ridgefield, CT)
- …programs, access, Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in ... areas of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Dow (Houston, TX)
- …available for a Regulatory Manager with focus on US Food and Drug Administration ( FDA ) regulations. The primary location listed is Midland, MI; however, ... At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX,… more
- Cardinal Health (Salem, OR)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- Stanford Health Care (Palo Alto, CA)
- …front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant ... and/or supplemental applications and post marketing reports per US FDA regulations. Responsible contact for US regulatory ...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- CVS Health (Alexandria, LA)
- …to address them + Communicate and educate staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, ... and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and...physician to receive hard copy of prescription and perform drug recall surveillance and reporting In this role, you… more
- Houston Methodist (Houston, TX)
- …developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the ... International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of… more
- BeOne Medicines (San Mateo, CA)
- …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …submission of high quality, regulatory submissions such to the Food and Drug Administration ( FDA ) and other Health Authorities, as required, within company ... Regulatory Affairs Specialist, assists in the management of regulatory submissions to ( FDA ) and other Health...and managing the status of submissions under review with FDA as per the Generic Drug User… more
- Abbott (Santa Clara, CA)
- …of medical device regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This ... + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical regulatory skills to proposed… more