<p>SUMMARY:</p> <p>The Regulatory Affairs Manager utilizes compliance expertise to achieve new animal product approvals (drug, device and nutritional) and maintain currently approved products on the market. This position compiles, reviews and submits materials for (A)NADA and (J)INAD regulatory submissions, providing technical and tactical regulatory operations required to manage pre- and post-approval projects and submissions to ensure regulatory compliance and reduce risk of FDA enforcement action.</p> <p>RESPONSIBILITIES:</p> <ul> <li>Prepare and submit electronic submissions to the FDA Center for Veterinary Medicine (CVM), review associated technical documentation and ensure all post-approval regulatory requirements and commitments are met (MCSR, DER, 2301). Engage with CVM on submissions when necessary, and track through full submission process to approval. </li><li>Partner with marketing as subject matter expert to provide guidance and perform review of all approved and unapproved product labels, promotional materials, and website content. </li><li>Manage the FDA Structured Product Labeling (SPL) database: create new listings, submit updates, perform annual review and certification. Monitor and implement State-related regulatory and labeling updates to ensure ongoing compliance across all jurisdictions. </li><li>Ensure compliance with DEA regulations, including registration maintenance (year-end report, quota request, import/export permit), monitoring and reporting of controlled substance inventory, inspection readiness, and coordination of required documentation for procurement and usage. </li><li>Work cross-functionally across Quality, Marketing, Sales, and Operations as a subject matter expert on regulatory requirements on department-specific deliverables. Shapes submission decisions, anticipates regulatory challenges, and reduces risk. </li><li>Evaluate pre- and post-approval change controls, labels, and manufacturing changes to determine impact and submission requirements to align with regulatory strategies. </li><li>Work with product development managers to prepare and submit major and minor pre-approval technical sections, process project-related invoices, track project budgets, and assist with nonclinical and clinical regulatory activities as needed. </li><li>All tasks as requested or assigned. </li></ul> <p>QUALIFICATIONS AND REQUIREMENTS:</p> <ul> <li>Bachelor's Degree in Life Science or related field MS, PhD. in Life Science or related field preferred. </li><li>B.S. or M.S. with 8+ years' experience in pharmaceutical or FDA/CVM related industry; PhD with 5+ years' experience in pharmaceutical or FDA/CVM related industry. </li><li>Experience in animal health, compliance, and/or regulatory affairs required. </li><li>Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) required. </li><li>Experience with eSubmitter software, Master Control (or related QMS) and Microsoft Dynamics 365 (or related ERP) preferred. </li><li>Travel up to 10% </li></ul>