- ALBEMARLE (Charlotte, NC)
- …Regulatory, Hazard Communication and Toxicology staff. This leader will ensure regulatory compliance , and the safety of the products placed into the Americas ... the requisite authorizations under Americas chemical control regulations (eg, TSCA, FIFRA, FDA , etc.) before and while doing business in markets where such programs… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Manager. Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in line with standards prescribed by USFDA. Maintain ... compliance to data integrity and cGMP in QC lab...to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of… more
- Merck (Wilson, NC)
- …including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues. + Responsible for the accuracy ... Divisional policies and Wilson site procedure for safety, quality, and regulatory compliance . + Review literature pertaining to pharmaceutical packaging in order to… more
- United Therapeutics (Raleigh, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... teams such as: marketing, clinical development, medical affairs, public policy, and compliance to ensure that patient advocacy and medical society initiatives are… more
- 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 ... protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy… 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 ... role and as part of the Medical Quality and Compliance team you will be working alongside and as...market + Maintain up-to-date knowledge of advertising regulations from FDA / PhRMA, healthcare landscape, including attending relevant training, and… more
- United Therapeutics (Research Triangle Park, NC)
- …automation, orchestration, and scale + Knowledge of specific pharmaceutical and medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- ThermoFisher Scientific (Greenville, NC)
- …an Engineer III, Validation, you will provide direct quality support through compliance , regulatory assessment, and validation activities. You will lead and guide ... approve, track, and present documents and procedures required for pharmaceutical regulations' compliance . **A Day in the Life:** + Prepare, review, and approve… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …site DI Plan(s) and will collaborate across functions and sites to ensure full compliance are maintained. Additionally, the DIO will serve as an active member of the ... + Leads data integrity training to ensure awareness and compliance to data integrity regulatory and program requirements. +...to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance KNOWLEDGE, SKILLS AND ABILITIES: Education:… more
- Chiesi (Cary, NC)
- …get content approved to support business needs + Ensures regulatory compliance while effectively managing business risks + Understands global promotional strategies ... published by OPDP, and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing Information are reflected in… more