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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