Manager, Regulatory Affairs

Overview

This position supports both their individualand overall departmental goals regarding the number of filings to be submittedand approved yearly by planning, managing and assuring the quality of theapplications (ANDA, NDA, 505(b)2, etc.) that are filed on time, and respondingto subsequent deficiencies completely and on time. The candidate will beexpected to mentor and provide regulatory support and management to associateswithin the group, as well as within the organization. Requires minimal to nosupervision.

Responsibilities

Managesdepartment resources by providing guidance, coaching, and developmentopportunities through on the job experience, mentorship, and training. Inspiresand motivates team members to achieve departmental and functional goals.Evaluates performance and provides specific, relative, and timely feedback toindividual to ensure consistency in regulatory practices.