The Associate, Regulatory Affairs assists the regulatory representative to Project Teams for assigned projects or products and by providing regulatory tactical support and strategy under guidance from manager. 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 in conjunction with more senior members of the department.
Assists Managers, Directors, or Senior Directors of Regulatory Affairs in providing guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.
Assists in ensuring the overall quality of regulatory submissions.
Works on initiatives as a regulatory representative
Education and Related Experience