Senior Scientist, Product Lead CMC Regulatory Affairs

Role: Senior Scientist, Product Lead in CMC Regulatory Affairs for Synthetics and New Modalities within Innovative Medicine R&D. The position involves shaping regulatory strategies for global CMC development, preparing dossiers for health authorities, and supporting regulatory filings for development and marketed products. Responsibilities include integrating disease biology, pharmacology, and clinical data to inform scientific strategies, representing CMC RA on cross-functional teams, and ensuring compliance with global regulatory requirements. The role also entails managing documentation for submissions, responding to health authority inquiries, and supporting inspections. Qualifications: Bachelor’s degree in Biological, Pharmaceutical, Chemical, or Engineering Sciences (advanced degree preferred); at least 4 years of pharmaceutical or healthcare industry experience, including drug development, analytical, or manufacturing backgrounds; familiarity with global health authority regulations; strong communication, attention to detail, and regulatory strategy presentation skills. High-value specifics: focus on innovative modalities like synthetics and new modalities, involvement in global development projects, regulatory dossier preparation, and potential contributions to post-approval lifecycle management. Hybrid work setup in NJ or PA, with no explicit travel requirements specified.