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Compliance Officer

2 months ago

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

About the Role:

Katalyst Healthcares & Life Sciences is seeking a highly skilled Regulatory Compliance Manager to support the Sr. Director of Regulatory Process and Compliance in maintaining client compliance with regulatory requirements.

Key Responsibilities:

  • 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.