Associate be responsible for successfully tracking and maintaining various regulatory spreadsheets and databases. With supervision, helps to author, compile, review and submit high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Under supervision, coordinates and writes clear, concise and accurate responses to inquiries from FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files. Works on projects and helps to solve problems where analysis of the situation or data requires evaluation and sound-interpretation of regulatory requirements and/or guidelines.