Regulatory Affairs Specialist

Job Summary Research Triangle Park (RTP), NC. Position Overview Piper Companies is seeking a Regulatory Affairs Specialist I – CMC to support our end client's Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. This position is onsite in Research Triangle Park (RTP), NC. Responsibilities Author, review, and manage CMC regulatory documents and submission workflows. Support preparation and maintenance of regulatory submissions, including initial IND submissions for Phase I, II, and III clinical studies, New Drug Applications (NDAs), post‑approval NDA supplements, CBE‑30 supplements, and Annual Reports. Prepare, review, and maintain Module 3 (CMC) documentation for regulatory submissions. Coordinate with cross‑functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content. Ensure regulatory submissions are accurate, complete, and compliant with FDA regulations and internal timelines. Manage documentation and submission activities within Veeva RIM or a similar Regulatory Information Management system. Maintain regulatory documentation within electronic document management systems (EDMS). Support regulatory compliance initiatives and continuous process improvement activities. Required Qualifications 2–3+ years of direct CMC Regulatory Affairs experience within the pharmaceutical or biotechnology industry. Experience authoring and reviewing CMC regulatory documentation, including Module 3 content. Working knowledge of FDA regulatory submission requirements, including INDs, NDAs, post‑approval supplements, and annual reports. Experience using Veeva RIM or a similar Regulatory Information Management system. Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline preferred. Proficiency with Microsoft Office Suite (Word, Excel, Outlook, and PowerPoint). Familiarity with electronic document management systems (EDMS) and regulatory publishing workflows. Strong organizational skills with exceptional attention to detail and the ability to manage multiple priorities in a fast‑paced environment. Excellent written and verbal communication skills with the ability to work effectively on cross‑functional teams. Preferred Qualifications Experience supporting small‑molecule pharmaceutical products. Experience supporting regulatory activities across multiple stages of development, from early‑phase INDs through post‑approval lifecycle management. Knowledge of FDA CMC regulations and global regulatory documentation best practices. Compensation Competitive hourly rate based on experience. Comprehensive benefits package available to eligible consultants. #J-18808-Ljbffr