- BioFire Diagnostics, LLC. (Durham, NC)
- …processes are properly logged, monitored, and aligned to enterprise standards. Policy & Regulatory Monitoring + Track and manage internal and external policy and ... regulatory changes that may impact communications, brand reputation, or...documentation + Budget management + Executive communication and data story telling Domestic Travel - 10% International Travel -… more
- Amentum (Raleigh, NC)
- …Continuously assess and improve controls to address emerging cybersecurity threats, regulatory changes, and industry best practices. + **Audits, Risk Assessments & ... ensuring timely documentation and resolution of audit findings. Support regulatory inspections and certification processes. + **Documentation, Reporting & Metrics:**… more
- Reckitt (Wilson, NC)
- …process improvements with engineering, maintenance, and production teams. + Maintain regulatory alignment (GMP, FDA, ISO, EHS) and current schematics. + Execute ... operational excellence. **_This role is not currently sponsoring visas or considering international movement at this time._** **The experience we're looking for** +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global ... of manufacturing operations. Other duties include responsibility for safety, regulatory and/or environmental compliance; ensuring continuous improvement of processes;… more
- CDM Smith (Hickory, NC)
- …or special case designs, studies, etc. -Maintains client, industry, and regulatory agency contacts; participates in relevant professional organizations; attends and ... contact. -Supports project delivery team through interpretation of technical and regulatory issues, assisting with project scoping and budgeting, and achieving… more
- IQVIA (Durham, NC)
- …and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Work with sites to adapt, drive, ... issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF)… more
- CDM Smith (Winston Salem, NC)
- …on the impact of long-range planning, introduction of new programs/strategies and regulatory action. * Works with the CEO and executives to identify potential ... and the Board of Directors. * Leads and is accountable for all regulatory compliance and ethical financial practices. * Identifies and evaluates M&A opportunities,… more
- Lilly (Durham, NC)
- …of specifications, review and approval of cGMP documents, and maintaining regulatory compliance. **Responsibilities:** + Support the site in the development and ... self-led inspections and/or provide support during internal inspections. + Support regulatory inspection activities as needed by providing documentation and SME… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …assigned areas within the TA. + Engages with a network of international scientific leaders and other key stakeholders (therapeutic guideline committees, payers, ... and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay...evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive… more
- Lowe's (Mooresville, NC)
- …conducting effective research, managing, tracking, and reporting on various international , federal, state, local obligations, and accounting transactions to ensure ... this role supports the execution of internal controls over financial and regulatory reporting, by applying accounting judgment and knowledge of basic GAAP and… more