- Beckman Coulter Diagnostics (Miami, FL)
- …and federal environmental regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single Audit Program (MDSAP), ... more
- Aldevron (Fargo, ND)
- …method validation, transfer, and development, demonstrated through publications or previous experience. Regulatory Knowledge: Strong understanding of FDA , EU, and ... more
- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... more
- Butterball (Yellville, AR)
- …practices are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary documentation.. Partners ... more
- 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
- 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
- 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
- Sanofi Group (Cambridge, MA)
- …launch strategies. Additionally, you will be the primary therapeutic area liaison with FDA 's Office of Prescription Drug Promotion (OPDP) for drugs, Advertising ... 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
