Director, Regulatory CMC

Role: Senior Regulatory CMC Specialist responsible for executing high-quality, compliant regulatory chemistry, manufacturing, and controls (CMC) deliverables for biopharmaceutical programs addressing rare neuroendocrine diseases. Objectives include managing CMC documents for global submissions, supporting filing strategies, and ensuring regulatory compliance across development, registration, and lifecycle phases. Responsibilities encompass authoring and reviewing dossiers such as INDs, IMPDs, MAAs, and variations; coordinating cross-functional inputs; tracking commitments and questions; preparing meeting materials; and contributing to process improvements. Requirements include a B.S. in science or life sciences with at least 10 years’ experience in regulatory CMC, manufacturing, or quality within pharma, with specific expertise in peptides and injectable dosage forms or injection devices. Experience supporting regulatory filings for clinical trials, marketing applications, and post-approval is necessary; familiarity with global ICH region requirements is essential. Preferred skills include supporting rare disease programs and working in a fast-paced, cross-functional environment. High-value specifics involve biologics or peptides, early to late development stages, and global regulatory compliance. The role is based in Boston within a hybrid work model and may involve some travel.