The Manager, Regulatory Affairs serves as regulatory representative to Project Teams for assigned projects or products and provides regulatory tactical support and strategy. Liaises with regulatory agencies in order to expedite approval of pending registration and answer questions. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug.
Recommends guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.
Responsible for the overall quality of regulatory submissions. Manages, Reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards. Provides appropriate regulatory guidance to Project Teams for the development of the above regulatory submissions.
Interacts with Project Managers at FDA (pre and post submission).
For assigned projects, provides effective oversight for regulatory submissions that are outsourced.
Education and Related Experience