Regulatory Specialist

<h1></h1><h1><b>Job Summary</b></h1><p></p>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.<br><br>Rate of Pay: $100,706.01 to $110,422.12 USD Annual<h1></h1><p style="text-align:inherit"></p><h1><b>Responsibilities</b></h1><h1></h1><p><b>Duties:</b></p><ul><li>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%).</li><li>Review technical documents for cGMP and regulatory compliance (10%).</li><li>Serve as an expert in technical areas in dealing with development and manufacturing organizations in U.S. and abroad (5%).</li><li>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%).</li><li>Develop regulatory strategy for difficult issues which could significantly impact project timelines and costs (5%).</li><li>Provide regulatory decisions with regard to acceptability of submission documents and decisions (10%).</li><li>File all applications in accordance with predetermined timelines (15%).</li><li>Share with others best practices for planning, organization and time management (5%).</li><li>Function as a Special Projects Manager to support COO office on priorities, including project management, communications material development (5%).</li></ul><p></p><p>Work from office 3 days per week and 2 days per week remote.</p><p></p><p><b>Requirements:</b></p><ul><li>Must have a Bachelor’s degree in Chemistry, Biochemistry, Biology, Biotechnology or related field and one (1) year of experience in pharmaceutical regulatory affairs or other scientific area supporting pharmaceutical regulatory affairs.</li><li>Must also possess the following: demonstrated expertise preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA; demonstrated expertise successfully completing supplements and/or amendments approved by the FDA; and, demonstrated expertise understanding CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals.</li></ul><h1></h1><p style="text-align:inherit"></p><h1><b><span>Additional Information</span></b></h1><p style="text-align:inherit"></p><p style="text-align:left"><span>We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, <span><span><span><span class="WCO0">disability, 401K</span></span></span></span> with company </span><span>contribution</span><span>, and wellness program. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Fresenius Kabi is an Equal <span><span><span><span class="WCO0">Opportunity/Affirmative</span></span></span></span> Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.</span></p>