Regulatory Affairs Specialist (CMC)

Piper Companies is seeking a Regulatory Affairs Specialist (CMC) to support a well-established biotechnology client out of the Durham, NC area. The Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions. Responsibilities Prepare, author, review, and compile CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, ANDAs, MAAs) Support the preparation of amendments, supplements, annual reports, and variations Ensure all CMC documentation complies with regional regulatory requirements (FDA, EMA, ICH, etc.) Manage and maintain regulatory dossiers in electronic submission formats (eCTD) Contribute to the development and implementation of CMC regulatory strategies throughout the product lifecycle Support preparation of responses to regulatory agency questions and deficiency letters Participate in inspections and audits as needed Collaborate closely with Quality, Manufacturing, Supply Chain, and R&D teams to gather and verify accurate CMC data Track submission timelines and ensure timely delivery of regulatory documents Qualifications 2–5+ years of experience in regulatory affairs, preferably with a focus on CMC Experience with regulatory submissions in the pharmaceutical or biotechnology industry Familiarity with global regulatory requirements (FDA, EMA, ICH guidelines) Strong knowledge of CMC processes including drug substance and drug product development Experience with eCTD submission systems and document management tools (Veeva) Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field required Compensation Salary: $60,000 - $85,000 annually, commensurate with experience Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays 1 hybrid day per week #J-18808-Ljbffr Piper Companies