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: NDAs, Amendments, Supplements, Annual Reports and 505(b)(2) files, Health Authority Meeting Requests and Briefing Packages. 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.
The Associate, Regulatory Affairs reports into Vice President of Regulatory Affairs and is based in Morristown, New Jersey.