Seeking an experienced Pharmaceutical Development Director, the full-time position will manage the preparation of CMC documents for regulatory submissions and support drug product programs while collaborating with cross-functional teams in a hybrid work environment. Key responsibilities Serve as the primary author and coordinator for drug product CMC sections of regulatory submissions and supporting documents Translate technical data into clear, accurate, phase-appropriate regulatory narratives and summaries Lead document planning, content integration, and finalization of submission-ready CMC documents Required qualifications BA/BS or higher degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline with relevant drug product development experience Experience in sterile drug product development and authoring CMC content for regulatory submissions Ability to write clearly and persuasively for regulatory audiences while maintaining scientific rigor Knowledge of FDA, ICH, USP, ISO, and other relevant regulatory guidance applicable to pharmaceutical development Excellent organizational and project management skills, capable of managing multiple time-sensitive deliverables independently