Senior Scientist, Product Lead CMC Regulatory Affairs

Role: Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities, supporting development and regulatory strategies for innovative medicines. Responsibilities include integrating disease biology, pharmacology, and clinical data into scientific strategy; developing global CMC regulatory approaches and dossiers; leading CMC regulatory activities in cross-functional teams; preparing and managing regulatory submissions, responses, and documentation for health authorities; and ensuring compliance with regulatory standards. The role involves supporting both development compounds and marketed products, providing regulatory input for lifecycle management, and supporting inspections. Qualifications: Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences; 4+ years’ industry experience, including drug development, analytical development, or manufacturing; familiarity with global health authority regulations; strong communication and regulatory strategy skills. Preferred: advanced degrees (Master’s, PharmD, Ph.D.). High-Value: focus on CMC regulatory strategies for biologics, small molecules, or novel modalities, supporting multi-stage development (IND, CTA, NDA/BLA), across global markets. The position offers hybrid work in NJ or PA with potential for international collaboration.