- Boehringer Ingelheim (Ridgefield, CT)
- …associated with Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in ... more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … regulatory matters, including labeling negotiations, advertising and promotion, drug safety, market research, scientific exchange, market access and patient ... 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 ... more
- Astellas Pharma (Northbrook, IL)
- …payments (USAN generic drug names) + Serving as primary contact for the FDA Drug Shortages Group to address FDA queries concerning product availability ... more
- BeiGene (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 ... more
- Teva Pharmaceuticals (Parsippany, NJ)
- … submissions (ie ANDAs, amendments, supplements, etc.) to the Food and Drug Administration ( FDA ) to ensure compliance with applicable regulations and ... more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... more
- Takeda Pharmaceuticals (Lexington, MA)
- …enforcement letters) or competitor complaints. + Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and ... 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 ... more
- Fresenius Medical Center (Waltham, MA)
- …principles are required. Must be knowledgeable of and have experience in applying FDA drug regulations; possess strong oral and written communication skills; and ... more
- J&J Family of Companies (Spring House, PA)
- …as appropriate. + Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards. **In ... more
- Dana-Farber Cancer Institute (Boston, MA)
- …reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, ... more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... 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 ... more
- Globus Medical, Inc. (Audubon, PA)
- …clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... more
- IQVIA (Falls Church, VA)
- …in both the guidance and the practice of developing strategies and evidence to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory ... more
- Abbott (Atlanta, GA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... more
- Interstate Blood Bank (Vista, CA)
- …GBS DDL. * Assist Regulatory Management with product deviation reporting to the FDA . * Updates and distributes annual facility FDA reports. * Assists with ... more
- Corning Incorporated (Tewksbury, MA)
- …Current understanding of FDA and rest of world compliance trends in Regulatory Affairs as relates to biological products, medical device, IVDs etc. + Maintain ... more