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Clinical Regulatory Affairs

Job Summary

Responsible for the overall planning and direction of clinical regulatory activities. Develops and implements strategies with the goal of approval of regulatory submission.

Primary responsibilities

  • Direct and oversee short-term and long-term planning of regulatory submission initiatives.
  • Interpret corporate policy.
  • Develop and implement strategies for the earliest possible approval of regulatory submission.
  • Manage regulatory teams and provide guidance.
  • Review and change ongoing projects as needed.
  • Plan, schedule and direct activities and programs through regulatory staff.
  • Negotiate with outside agencies as needed to resolve key regulatory issues.
  • Expedite approvals of product and services.
  • Prepare responses to inquires from regulatory authorities.
  • Communicate changes and updates to staff and management.
  • Prepare and submit applications and reports.
  • Submit supplements and amendments to update registered product information.
  • Monitor and update national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel.
  • Hire, train, and supervise regulatory staff.
  • Handle budget requirements and monitor project and program costs.
  • Review, evaluate, and compile files and reports for submission.
  • Coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration.
  • Prepare outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
  • Provide guidance to project teams and staff.

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