- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. ... Quality Control departments. + Represent Glenmark as appropriate in FDA , notified body, internal and other regulatory ...in FDA , notified body, internal and other regulatory audits. + Work in close collaboration and support… more
- Sumitomo Pharma (Raleigh, NC)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA… more
- J&J Family of Companies (Wilson, NC)
- …CSV support coordination. + Deep understanding and experience in application of global regulatory ( FDA , EMA, ICH, etc.) guidelines in a biological or ... compliance or quality system issues as they arise + Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Fujifilm (Raleigh, NC)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Herbalife (Winston Salem, NC)
- …in Automation/Electronics or Industrial Maintenance Technology/Mechatronics * Food and Drug Administration ( FDA ) or other regulatory experience * 5+ years of ... work experience in a high-speed manufacturing environment * Food manufacturing or packaging experience, and/or blending equipment, batching operation systems **PHYSICAL DEMANDS:** In general, the following physical demands are representative of those that must… more
- ThermoFisher Scientific (Greenville, NC)
- …**Knowledge, Skills, and Abilities** + Understanding of EM techniques, equipment, and regulatory requirements. + Familiarity with GMP, FDA , and other ... This role involves developing sampling programs in alignment with regulatory standards, coordinating environmental monitoring activities, analyzing data for… more
- ThermoFisher Scientific (Greenville, NC)
- …efficiencies to address shortcomings in processes and systems. + Host and coordinate regulatory inspections performed by the FDA , MCA, and other regulatory ... III, Validation, you will provide direct quality support through compliance, regulatory assessment, and validation activities. You will lead and guide lower-level… more
- Fujifilm (Holly Springs, NC)
- …electrical, plumbing, chemical treatment, and control systems + Familiarity with GMP, FDA , and other regulatory requirements + Effective communication, both ... and daily operational activities while ensuring compliance with safety, regulatory , and Good Manufacturing Practices (GMP) standards. Additionally, this role… more
- Lilly (Concord, NC)
- …awareness within the organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping ... and equipment specific to parenteral products. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and experience with regulatory inspections.… more