- Sumitomo Pharma (Raleigh, NC)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA filings. +… more
- Cardinal Health (Raleigh, NC)
- …to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg, ... industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals),… more
- Merck (Raleigh, NC)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... Cattle, Biopharmaceuticals, Cattle Feeding, Cattle Production, Customer-Focused, Data Analysis, FDA Regulations, Feedlots, Field Sales Support, Livestock Management, Nutritional… more
- Kedplasma (Rocky Mount, NC)
- …Director. Operates within the scope of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... that meet the criteria of normal plasma donors in accordance with SOPs, the FDA , OSHA, CLIA and cGMP and company policies as well as educational experience. +… more
- Kedplasma (Hickory, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and care of the donor… more
- Actalent (Cary, NC)
- …to patients. Responsibilities + Counsel and educate existing patients on REMS FDA -mandated medications, including reading a list of statements to patients verbatim ... report adverse events (AEs) and product complaints (PCs) to the manufacturer, FDA , and/or other governing authorities. + Provide specialty drug verification and… more
- IQVIA (Durham, NC)
- …approval and expert advice to our clients in line with the requirements of the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and medical devices on assets for ... US market + Maintain up-to-date knowledge of advertising regulations from FDA / PhRMA, healthcare landscape, including attending relevant training, and share relevant… more
- Fujifilm (Holly Springs, NC)
- …of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations + Experience in Drug Substance Manufacturing (DSM), Drug Product(DP), and/or ... Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations + Prior experience working in a CDMO environment **WORKING… 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 ... train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location**… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... specific pharmaceutical and medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, HIPAA/HITECH) + Present ideas and information accurately and be… more