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Clinical Regulatory Affairs Professional

tunities located in: NY, NJ, PA, MA, NC 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.

Los Angeles, California