- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- … drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, ... other scientific field. + 6-8 years of relevant experience in pharmaceutical regulatory /labeling environment and/or drug development + Knowledge of scientific… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an exceptional rating from the National… more
- Cambrex High Point (Charles City, IA)
- …a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug ... North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances,… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... all defined QC testing activities including incoming materials, in-process samples, and drug substance and drug product testing, including oversight of assigned… more
- Charles River Laboratories (Northridge, CA)
- …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 ... requirements, USP and ISO compliance; direct experience with in-person regulatory inspections/audits highly desired. + Specialize with downstream process analysis,… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Job ... quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board...all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review… more
- Roche (Indianapolis, IN)
- …developing digital outcome measures + FDA /EMA regulatory interactions or regulatory consortias regarding clinical drug development and novel drug ... customers with needs in areas of Disease understanding / Drug portfolio decision-making (phase I-II) / Regulatory .../ Drug portfolio decision-making (phase I-II) / Regulatory treatment approval (phase III-IV) / Clinical trial participant… more
- Stanford University (Stanford, CA)
- …regulatory compliance. + Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Boehringer Ingelheim (Duluth, GA)
- …pharmacovigilance compliance with all competent authorities (including but not limited to FDA , USDA-APHIS, EMA, CFIA etc.) as described in the corporate and BIAH ... PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European...of ADE analysis, PV trending and/or signal detection. Ensures regulatory compliance of Pharmaceutical Advertising and Promotional Labeling by… more
- AbbVie (North Chicago, IL)
- …Affairs teams. Advise on a broad range of matters involving the Food and Drug Administration ( FDA ), Federal Trade Commission (FTC), Office of Inspector General ... for US and foreign patent prosecution, listing patents in the FDA 's Orange Book, analyzing freedom-to-operate issues, addressing contractual issues, evaluating… more
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