Cambridge, MA30+ days ago
em> Helps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.