Senior Manager/Associate Director, Regulatory Affairs CMC (EDG-2026020)

This position will contribute regulatory CMC experience to Edgewise cardiovascular and skeletal muscle therapeutic development teams. - Responsible for regulatory CMC contribution to product development and registration for small molecule investigational products. Conduct risk assessments and recommend development options. - Oversees the writing, editing, reviewing and compiling CMC documents needed for regulatory submission activities for US and global assigned products. The submissions include IMPD, INDs, CTAs, NDAs, MAAs, meeting requests, briefing documents, and annual reports, as well as contribution from a CMC perspective on other submissions and clinical documents. - Provides critical review of CMC documentation supporting regulatory submissions and communications. - Collaborates cross-functionally with Regulatory Affairs, CMC, and Quality to ensure compliance such as manufacturing records review, release and change controls. - Prepares regulatory submissions using regulatory document management systems and archival of regulatory documentation. - Ensures CMC regulatory milestones are met to support regulatory submission and overall business goals of the Company. - Contributes to the development of the overall regulatory strategies. - Oversees external vendors and contractors with responsibility for providing regulatory support to ensure project deliverables are achieved. - Builds professional and effective external relationships crucial to the success of the organization. - Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders. - Other duties as assigned.