Regulatory Specialist

Job description

Job Summary The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no direct reports. Rate of Pay: $100,706.01 to $110,422.12 USD Annual Duties: Work from office 3 days per week and 2 days per week remote. Requirements: - Represent Regulatory Affairs Dept. on project teams and provide regulatory guidance to clearly and convincingly communicate complex issues as well as share expert knowledge of complex issues (15%). - Review technical documents for cGMP and regulatory compliance (10%). - Serve as an expert in technical areas in dealing with development and manufacturing organizations in U.S. and abroad (5%). - Prepare and file high-quality submissions to regulatory authorities including A/NDA’s, Supplements, Amendments, Annual Reports and DMF Updates (25%). Communicate importance of quality assurance (5%). - Develop regulatory strategy for diffi...