- Reckitt (Wilson, NC)
- …/ utility operations. + Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11 requirements. + Validate and maintain ... technologies for performance optimization. + Drive regulatory alignment (GMP, FDA , ISO, EHS) across automation activities and support audits, validation,… more
- Biomat USA, Inc. (Kannapolis, NC)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Sumitomo Pharma (Raleigh, NC)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on ...FDA . + Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion… more
- Novant Health (Winston Salem, NC)
- …Complies with all regulatory requirements related to the conduct of research ( FDA , GCP, IRB, ICH). Assures regulatory submissions for all protocols, adverse events, ... Works with Sr. team members to prepare for and attend sponsor and/or FDA audits. Develop knowledge to understand protocol feasibility. With leader or senior team… more
- Lilly (Durham, NC)
- …within the organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection ... specific to parenteral products. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and experience with regulatory inspections. **Additional Preferences**… more
- Medtronic (Charlotte, NC)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... Ability to read and understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable skills in Microsoft Office… more
- Reynolds American (Winston Salem, NC)
- …experience. + Previous experience working in a laboratory setting. + Knowledge of FDA regulation processes or experience in another FDA -related industry. + Open ... to relocate globally. + High academic performance. + Prior internship, practicum experience; student organization or other leadership experience. + Demonstrated leadership skills. + Strong business acumen and a strategic mindset. + Intellectual curiosity and… more
- AbbVie (Raleigh, NC)
- …to present didactic and hands-on content in small groups + Knowledge of FDA and regulatory statutes as applied to Allergan Aesthetics products, with the ability ... (BCLS) required + Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… 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 ... + Demonstrated knowledge of regulatory/compliance requirements, including anti-kickback laws, FDA promotional regulations, Sunshine Act; and demonstrated knowledge of… 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 ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA filings. +… more