- Sumitomo Pharma (Raleigh, NC)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Reckitt (Wilson, NC)
- …+ Drive process improvements with engineering, maintenance, and production teams. + Maintain regulatory alignment (GMP, FDA , ISO, EHS) and current schematics. + ... of safety standards, regulatory compliance, and electrical codes..Strong knowledge of regulatory standards (eg, GMP, FDA , ISO 9001/13485). + PE (Professional… more
- United Therapeutics (Raleigh, NC)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR… more
- Chiesi (Cary, NC)
- …and rewarding work. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Kelly Services (Winston Salem, NC)
- …of Experiments (DoE), and statistical software (eg, JMP). + Comprehensive understanding of regulatory requirements from FDA , EMA, and ICH guidelines relevant to ... critical process parameter identification, technology transfer, validation activities, and regulatory submission preparation. Strong collaboration with internal stakeholders and… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …the Lineberger Comprehensive Cancer Center. The position is part of UNC's new NIH / FDA -funded Center for Tobacco Regulatory Science and Health Equity. We are ... broad theme of the UNC Center is building the science for effective FDA regulation of and communication about tobacco products disproportionately used by priority… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …appropriately measured and monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (eg, FDA 21 CFR, USP, EU Annex-1). This ... position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. QC Microbiology/EM Team Lead is a key position with expected knowledge and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …USP and EP/BP method/validation regulations. + Experience participating in the management of regulatory audits (ie FDA , MDSAP, ISO, OSHA, EPA, etc.). + ... working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry… more
- Canon USA & Affiliates (Raleigh, NC)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and… more