- Sanofi Group (Morristown, NJ)
- … interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle ... scoping and planning. + Good knowledge of industry best practices, global regulatory , processes, standards of drug development. **Demonstrate the following… more
- BeOne Medicines (Pennington, NJ)
- … preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements for submissions. + Effective communication, oral and ... troubleshooting, compliance related activities and provide technical support to Drug Substance manufacturing. Process monitoring and trend analysis of manufacturing… more
- University of Colorado (Aurora, CO)
- …Binder to ensure compliance with requirements of the Food and Drug Administration ( FDA ), study protocols, department, hospital/clinical standard operating ... responds to queries from Sponsor + Adhere to research regulatory standards + Maintain detailed records of studies including...Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration ( FDA ) audits and responses +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + ... each project. + Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence… more
- University of Maryland, Baltimore (Baltimore, MD)
- …be able to work closely with the radiation safety office with respect to regulatory compliance. This position will also participate in all facets of the radiology ... (MDE). 7. Other University of Maryland Medical Center committees . Radioactive Drug Research Committee (RDRC) is a committee of University of Maryland Medical… more
- Cardinal Health (Columbus, OH)
- …business and IT leadership teams, enterprise architecture, and key stakeholders. DSCSA ( Drug Supply Chain Security Act), enacted by Congress on November 27, 2013, ... are distributed in the United States. Aimed to enhance FDA 's ability to help protect consumers from exposure to...detection and removal of potentially dangerous drugs from the drug supply chain to protect US consumers. Additionally, the… more
- BPC Plasma, Inc. (Brookings, SD)
- …and ensures compliance with state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and ... standards in accordance with state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and… more
- Charles River Laboratories (Wilmington, MA)
- …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 ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Development to lead and manage a team developing innovative dosage forms and drug delivery systems. Reporting to the Sr. Director, Formulation Development, this role ... an expert in the areas of preformulation and formulation development studies, drug delivery technologies, and product development, this position will be responsible… 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