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.
