- CSL Plasma (Taylor, PA)
- …This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate… more
- Merck (West Point, PA)
- …strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of ... members. + Support preparation of submission packages, assist in addressing regulatory technical queries, and contribute technical expertise during regulatory … more
- Merck (West Point, PA)
- …strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of ... + Ensure readiness of E2E submission packages, proactive mitigation of regulatory technical queries, and contribute technical expertise during regulatory … more
- Merck (Upper Gwynedd, PA)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... to stay up to date regarding industry trends and diagnostic regulatory requirements. **Essential Job Requirements:** + Develop end-to-end diagnostic strategy in… more
- Merck (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Robert Half Management Resources (Philadelphia, PA)
- …contract basis. As an Audit Manager, the role requires expertise in regulatory compliance, Sarbanes-Oxley audits, and a deep understanding of the banking industry. ... do every single day: * Lead and oversee audits focused on regulatory compliance, Sarbanes-Oxley requirements, and internal control processes within the banking… more
- Merck (West Point, PA)
- …and clinical sample analysis with a commitment to scientific excellence and regulatory compliance. Position Summary We are seeking a highly talented and motivated ... data management systems that enhance sample tracking, bioanalytical data analysis, and regulatory compliance. The ideal candidate will have a strong background in… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, ... collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review INDs, NDAs, and other … more
- Williams Companies (Tunkhannock, PA)
- …in or handles the approved course of action, including required regulatory documentation + Participates in environmental project planning and implementation, ... environmental compliance programs + Cultivates relationships between Williams and regulatory agencies + Interprets applicable federal, state and local environmental… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …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