Regulatory Compliance Manager

2 months ago


South Plainfield NJ, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities and Requirements: Manager of Regulatory Compliance will support the Sr. Director of Regulatory Process and Compliance in maintaining client's compliance with regulatory requirements. This role will focus on assisting with the operational aspects of compliance activities, ensuring regulatory documentation is well-maintained, and supporting continuous compliance initiatives. Assist in providing hands-on support during regulatory inspections and internal audits. Ensure compliance-related documentation is organized, current, and readily accessible. Define, manage and maintain regulatory compliance metrics and systems in collaboration with the Sr. Director. Assist in identifying trends in recent regulatory inspections and translate these into recommendations to improve inspection preparedness. Support the development and delivery of compliance education programs for employees at all levels. Manage GRS training curricula and LMS training metrics in collaboration with GRS line managers. Assist in managing the GRS CAPA framework, providing support and follow-ups as needed. Monitor local and global compliance trends and report emerging regulatory issues. Assist in preparing reports and summaries for compliance evaluations and inspections. Collaboration and Solutions. Collaborate with R&D and Supply Chain departments to address operational quality and regulatory issues. Provide support in developing and implementing solutions.



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