- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and implementation of department Inspection Readiness plan + Collaborate with GXP Compliance /QA to identify trends resulting from GXP Compliance /QA audits +… more
- Biomat USA, Inc. (Greenville, NC)
- …of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations. **PRIMARY RESPONSIBILITIES** **:** + ... campaigns to attract and retain donors. + Maintains thorough familiarity and ensures compliance with state and federal regulations, US Food and Drug Administration (… more
- Biomat USA, Inc. (Kannapolis, NC)
- …for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance , and achievement of production goals. This role provides direct ... : Assists with operational management of a Plasma Collection Center, ensuring compliance with all applicable policies and regulations and overall performance and… more
- Sumitomo Pharma (Raleigh, NC)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... of promotional materials, eg Marketing and their Agencies, Legal, Compliance , and Medical Affairs. + Provide appropriate oversight of...with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on … more
- US Tech Solutions (Wilson, NC)
- …all departments in respect of document control to ensure business, quality and compliance goals are met + Partners with other Departments to ensure that ... when appropriate + Perform related duties as assigned by supervisor + Maintain compliance with all company policies and procedures **Experience:** + minimum of 3… more
- Fujifilm (Raleigh, NC)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Astellas Pharma (Sanford, NC)
- …of the Data Integrity program elements, including but not limited to, compliance gap assessments, collaborating with key stakeholders to ensure all elements of ... embedded and carried out through established work practices, to ensure compliance with Astellas local/global and regulatory requirements, and participating in… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements. + Ensures review of laboratory testing… more
- Merck (Raleigh, NC)
- …with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary ... submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with regulatory agencies (… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (eg, FDA 21 CFR, USP, EU Annex-1). This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. QC Microbiology/EM...for ensuring microbiological and EM testing is performed in compliance with procedures and GDP requirements including growth performance,… more