- 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
- Cardinal Health (Frankfort, KY)
- …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)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA...regulatory trends and developments for their impact on drug development activities and on existing development strategies. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Fellow will: * Act as a company liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. ... personnel, will liaise with FDA in written communication and participate in FDA meetings on regulatory issues. Will support/assist in the preparation of… 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
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… 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
- Organon & Co. (Jersey City, NJ)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug… more
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