- Reckitt (Wilson, NC)
- …that production is executed efficiently, safely, and in compliance with all regulatory , quality, and cGMP standards. The manager is accountable for delivering daily ... actions documented in SPIN. + Maintain full compliance with cGMP, FDA , and internal quality standards, overseeing batch documentation, deviation management, and… more
- Cambrex High Point (Durham, NC)
- …and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by ... managing* Good business acumen* Strong understanding of company SOPs, and regulatory guidance documents.* Strong knowledge of safety procedures and quality… more
- Cardinal Health (Raleigh, NC)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more
- ThermoFisher Scientific (Greenville, NC)
- …and implement systems to achieve process improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. ... with clients on agreements and resolving significant validation, product, and regulatory issues. + Prepare, review, and approve production, validation, and audit… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... studies, training and supporting technologists, maintaining QC/QA documentation and regulatory readiness, and contributing to our robust research and development… more
- ThermoFisher Scientific (Wilmington, NC)
- …trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with ... trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor… more
- Lilly (Concord, NC)
- …At least 2 years working within manufacturing/operations. + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or ... Environmental (HSE) functional groups + Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related… more
- ThermoFisher Scientific (Greenville, NC)
- …and implement systems to achieve process improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. ... negotiating with clients on agreements and resolving significant validation, product, and regulatory issues. **A Day in the Life:** + Prepare, review, and approve… more
- Sumitomo Pharma (Raleigh, NC)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Sumitomo Pharma (Raleigh, NC)
- …and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more