Associate Director, Regulatory Affairs, CMC- Biologics

Role: Associate Director, Regulatory Affairs CMC Development, focusing on global regulatory strategies for development-stage biopharmaceuticals, especially emerging modalities like oligonucleotides, antibody-drug conjugates, and next-generation delivery systems. Responsibilities include developing and executing CMC regulatory strategies for small molecules and biologics across early- and late-stage development, preparing regulatory documentation for clinical trials and marketing submissions, interpreting regulatory expectations for novel modalities, and serving as a strategic interface among Research, Development, and Regulatory teams. The role involves providing guidance on product characterization, control strategies, and regulatory classification, as well as contributing to regulatory intelligence activities and building CMC infrastructure. Qualifications include an advanced degree in a relevant scientific discipline, 8-10 years of industry experience with at least 5 years in Regulatory Affairs CMC, with proven expertise supporting therapeutic products through various development stages, particularly in complex or biologic modalities. Strong communication, cross-functional leadership, and ability to interpret and apply evolving regulatory policies are essential. High-value specifics: focus on complex biologics, oligonucleotide therapeutics, conjugated delivery systems, early- to late-stage development, global regulatory strategy, and cross-disciplinary collaboration. The position is hybrid, primarily based in Cambridge, MA or Philadelphia, PA.