Regulatory Specialist

Summary This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band Y and Band A. Responsibilities Supporting the preparation of regulatory documents and participates in professional development activities. Working closely with senior staff to support the preparation of regulatory documents and engages in structured professional development activities aimed at progressing toward independent practice. Assisting more experienced staff in the evaluation of regulatory submissions by reviewing of manufacturing information, quality data, and labeling materials following established ...