- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- Lilly (Concord, NC)
- …of cGMP requirements in medical device manufacturing. + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Excellent ... documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, etc. +… more
- Sumitomo Pharma (Raleigh, NC)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Kelly Services (Clayton, NC)
- …The position oversees quality systems, documentation, laboratory operations, regulatory compliance, employee development, staffing, training, and budget. **Primary ... Quality systems + Documentation and data integrity + Laboratory operations + Regulatory compliance (GMP/GxP) + Budget planning and oversight + Employee relations and… more
- Reynolds American (Winston Salem, NC)
- …of two primary areas: Scientific Research & Development (SR&D) and Scientific and Regulatory Affairs (S&RA). Within these spaces you could work in various spaces ... experience working in a laboratory setting. + Knowledge of FDA regulation processes or experience in another FDA... FDA regulation processes or experience in another FDA -related industry. + Open to relocate globally. + High… more
- Kedplasma (Hickory, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and...collection center for audits. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. +… more
- IQVIA (Durham, NC)
- …approval and expert advice to our clients in line with the requirements of the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and medical devices on assets for ... line with client's strategy and expectations + Effectively collaborate with Commercial, Regulatory , and Legal business partners to provide strategic input and drive… more
- Fujifilm (Holly Springs, NC)
- …strategies and procedures. This role facilitates improvement initiatives, supports regulatory agency, and third-party inspections, as needed. **Company Overview** ... of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations + Experience in Drug Substance Manufacturing (DSM), Drug Product(DP), and/or… 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 ... projects to ensure compliance of new systems with all mandatory legal, regulatory and security policy requirements Minimum Requirements + Associate Degree in… more
- Kelly Services (Wilson, NC)
- …review, approval, revision, and archival processes to ensure compliance with FDA /EMEA regulations. + Partner with internal teams including Learning & Development ... within the pharmaceutical or biologics industry. + Strong knowledge of FDA /EMEA regulations and GMP standards. + Hands-on experience with electronic document… more