- Sumitomo Pharma (Raleigh, NC)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary BLA ... Licenses supplements and other regulatory submissions to ensure that Grifols Plasma Operations is...to or including the US Food and Drug Administration ( FDA ), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics… more
- Cytel (Raleigh, NC)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder… more
- Novant Health (Charlotte, NC)
- …and resource allocation in dynamic environments. + Expertise in regulatory compliance (ICH/ FDA /OHRP), clinical trial budgeting/contracting, IRB/IBC relations, ... aspects of clinical research, including budgeting, performance management, and regulatory oversight, while fostering partnerships with pharmaceutical companies, academic… more
- Honeywell (Charlotte, NC)
- …with digital transformation initiatives in pharma or biotech. + Familiarity with global regulatory frameworks (eg, FDA , EMA, ISO). + Exposure to AI/ML, data ... value propositions tailored to life sciences personas. + Align messaging with regulatory , operational, and innovation drivers in manufacturing and quality. + Partner… more
- Reckitt (Wilson, NC)
- …standards, regulatory compliance, and electrical codes. + Strong knowledge of regulatory standards (eg, GMP, FDA , ISO 9001/13485). + Exceptionally Strong ... + Ensure systems comply with 21 CFR Part 11, FDA , EU Annex 11, and GxP standards. + Integrate...+ Maintain calibration and maintenance programs to meet GMP, FDA , ISO, and EHS standards. + Participate in audits… more
- ThermoFisher Scientific (Morrisville, NC)
- …(pharmaceuticals, biotech, medical devices). + Proficient knowledge of international quality and regulatory standards (such as FDA , EMA, ICH Q-series, ISO ... adjust the plan based on emerging risks, compliance history, regulatory updates, and business priorities. + Conduct audits in...+ Conduct audits in alignment with relevant standards (eg, FDA , EMA, ICH, ISO). Site Engagement & Audit Logistics… more
- ThermoFisher Scientific (Greenville, NC)
- …relevant standards. + Ensure all processes and documentation are up-to-date and ready for regulatory inspections (eg, FDA , EMA). + Act as a subject matter expert ... communication, leadership, and interpersonal skills. + Knowledge of quality systems, regulatory compliance (eg, cGMP), and audit preparation. + Ability to work… more
- Cytel (Raleigh, NC)
- …with a strong foundation in statistics. + Demonstrated experience interacting with regulatory agencies (eg, FDA , EMA) and contributing to health authority ... machine learning), with experience across all phases of development and global regulatory interactions. We are seeking an **Executive Consultant** - a seasoned… more
- US Foods (Lexington, NC)
- …safety, quality, and preventative maintenance. * Support the FSQA Manager to Ensure regulatory compliance with USDA, FDA , State and local authorities and act ... safety and raw material compliance specifications * Manage labeling compliance with USDA/ FDA regulations * Ensure complete data collection and trending on relevant… more