- Butterball (Yellville, AR)
- …practices are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary documentation.. Partners ... more
- Cytiva (Miami, FL)
- …to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits ... more
- Pall (Putnam, CT)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... more
- Beckman Coulter Diagnostics (Miami, FL)
- …the preparation and submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business ... more
- Cytiva (Pensacola, FL)
- …site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management ... more
- Aldevron (Madison, WI)
- …as HPLC, UV-Vis spectroscopy, and other relevant analytical methods. Familiarity with FDA , EMA, and other international regulatory bodies' requirements and ... more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... more
- Aldevron (Fargo, ND)
- …method validation, transfer, and development, demonstrated through publications or previous experience. Regulatory Knowledge: Strong understanding of FDA , EU, and ... more
- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... more
- Pall (Miami, FL)
- …for ensuring all incoming products meet technical, quality specifications and regulatory requirements.Develop the strategy and execute on a proactive risk-based ... more
- BeiGene (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... more
- Medtronic (Santa Rosa, CA)
- …requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions. + Maintain proficiency ... more
- Interstate Blood Bank (Vista, CA)
- …GBS DDL. * Assist Regulatory Management with product deviation reporting to the FDA . * Updates and distributes annual facility FDA reports. * Assists with ... more
- Boehringer Ingelheim (Ridgefield, CT)
- …reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant ... more
- Corteva Agriscience (Indianapolis, IN)
- …+ Quantitative analytical experience in a governmental regulated environment, such as EPA, FDA , EU regulatory bodies or equivalent. + Regulatory analytical ... more
- Fresenius Medical Center (Dallas, TX)
- …viable product strategies and product submission. + Assists in interactions with the FDA and other regulatory agencies. + Builds professional relationships with ... more
- J&J Family of Companies (Spring House, PA)
- …plans including BLA/NDAs, IND/CTAs & supplements. + Serve as primary point of contact for US FDA + Lead the regulatory response team for FDA and Health ... more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... more
- IQVIA (Falls Church, VA)
- …in both the guidance and the practice of developing strategies and evidence to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... more
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