- Mentor Technical Group (PR)
- …and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy ... efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). + Assures a streamlined and continuous… more
- Cedars-Sinai (Beverly Hills, CA)
- …best practice care delivery, collaborating with other healthcare team members. + ** Regulatory Compliance :** Utilize knowledge of regulating agencies (FDA, USP, ... etc.), best practice standards, and institutional policies and procedures to maintain regulatory compliance . + **Education and Training:** Participate in the… more
- Mentor Technical Group (Durham, NC)
- …and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy ... monitor packaging equipment to ensure accurate and efficient product packaging in compliance with GMP standards. + Perform line clearance, setup, and changeover of… more
- Genentech (South San Francisco, CA)
- …and implementing CRM strategies that balance business needs, user experience, and compliance requirements. + Strong understanding of regulatory , legal, and ... & meaningful patient and customer experiences that maximize patient impact while keeping compliance at the forefront. **Location** + This position is based in South… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and analyzes trends to proactively mitigate equipment and reagent performance issues. Compliance : + Maintain current knowledge of regulatory and industry ... monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (eg, FDA 21 CFR, USP, EU Annex-1)....is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. QC Microbiology/EM Team Lead is a key… more
- ThermoFisher Scientific (Greenville, NC)
- …of cGMPs and pharmaceutical contract manufacturing, Quality Assurance, Compliance , Quality Control and Regulatory Affairs. + Advanced problem-solving ... Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. +… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …and ensuring compliance for shipments, temp excursions, and quarantines + Compliance : ESR Processes, FMV, Safety, Regulatory , Training. Adheres to and ... 11+ years active work experience in area of clinical research and/or regulatory and//or field-based function in pharmaceutical and/or biotech company(ies) and… more
- Lilly (Indianapolis, IN)
- …documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, ... + Review/approve relevant technical documents, such as: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs,… more
- Merck (Cambridge, MA)
- …record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Sanofi Group (Morristown, NJ)
- …and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements + ... metadata specifications and project/study specific data requirements + Lead regulatory submission activities, including electronic submission packages + Supervise… more