Senior Manager, Regulatory Affairs CMC

Role: Senior Manager, Regulatory Affairs – CMC at a cardiovascular biopharmaceutical company, focusing on regulatory submission strategy and execution for small molecule drug development. Responsibilities: lead/coordinating CMC regulatory filings, prepare high-quality dossiers for US and EU markets, collaborate with Regulatory, Quality, and Supply Chain teams, and monitor regulatory environment changes. Support quality systems like change control and VEEVA-RIM, communicate risks, and assist with agency interactions and internal communications. Qualifications: 5+ years of industry experience in pharma/biotech, including 2-3 years in Regulatory Affairs-CMC; bachelor’s in a science or related field, with advanced degrees preferred. High-value: experience with global regulatory guidelines for small molecules, late-stage drug development, and regulatory submission processes (eCTD, VEEVA). Knowledge of GMP and GDP standards essential. Collaboration: cross-functional with Regulatory, QA, Tech Ops, and Supply Chain. Work setup: location not specified; no travel indicated.