Director Regulatory Affairs CMC

Director, Regulatory CMC (Hybrid - San Francisco Bay Area)We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small molecule therapeutics. The organization is advancing multiple programs across early and late-stage development and is building out its Regulatory CMC leadership to support global filings and accelerate programs toward commercialization.This is a high-impact, strategic leadership role for someone who thrives at the intersection of regulatory strategy, CMC development, and cross-functional program execution in a fast-paced, science-driven environment.The Director, Regulatory CMC will lead global CMC regulatory strategy and execution across multiple programs, including biologics and small molecules. This individual will serve as a key interface between Regulatory Affairs, CMC, Quality, Technical Operations, and external partners to ensure alignment with global regulatory expectations and successful IND/CTA, BLA, and NDA submissions.This is a hybrid role based in the San Francisco Bay Area, requiring on-site collaboration several days per week.Key ResponsibilitiesLead global Regulatory CMC strategy across clinical and late-stage development programs (biologics and small molecules)Author, review, and oversee high-quality CMC sections for INDs, IMPDs, CTAs, BLAs, and NDAsProvide strategic regulatory guidance on CMC development plans, comparability strategies, process changes, and lifecycle managementAct as primary CMC regulatory liaison with global health authorities, including FDA and EMAPartner closely with Process Development, Manufacturing, Analytical, and Quality teams to ensure regulatory alignmentSupport regulatory responses to agency questions, deficiencies, and inspection readiness activitiesDrive regulatory risk assessments and mitigation strategies for complex CMC issuesContribute to development of regulatory policies, templates, and best practices across the organizationMonitor evolving global regulatory guidance impacting CMC strategy and submissionsQualificationsAdvanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field (PhD preferred)10+ years of experience in Regulatory Affairs CMC within biotech or pharmaDemonstrated experience supporting both biologics and small molecule development programsStrong track record of successful IND/CTA filings and NDA/BLA submissionsDeep understanding of CMC regulatory requirements across US, EU, and other global regionsExperience interacting directly with regulatory agencies (FDA, EMA, and/or other health authorities)Strong cross-functional leadership skills in matrixed, fast-paced environmentsExcellent written and verbal communication skills with the ability to influence senior stakeholdersWhy This RoleOpportunity to shape CMC regulatory strategy across a dual-modality pipelineHigh visibility role reporting into senior regulatory leadershipStrong pipeline momentum with multiple clinical-stage assetsCollaborative, science-driven culture with significant growth trajectoryIf interested, please reach out to tanya.kochan@

Created: 2026-05-09