Director, Regulatory CMC

Who we are…

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

The Director of Regulatory CMC is responsible for leading the strategic development and execution of global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies across the company portfolio from early-stage discovery through all clinical phases to product registration and post-approval commercialization, as applicable. The primary focus is on managing clinical trial applications, marketing authorizations, and ensuring absolute compliance with global health authority regulations for both drug substance and drug product.

This role also serves as the critical regulatory liaison to bridge technical operations, quality assurance, and clinical development findings into compliant, high-quality, and inspection-ready global regulatory submissions.

• Lead the development, execution, and lifecycle management of global Regulatory CMCstrategies for clinical-stage and commercial products.
• Lead, author,review, and critically assess CMC regulatory documents and technical reports toensure accuracy, consistency, scientific rigor, and suitability for global regulatory filings.
• Provide strategic Regulatory CMC leadership and guidance to process chemistry,formulation development, analytical, quality, manufacturing, clinical, supply chain, and commercial teams to ensure development and lifecycle activities are aligned with global regulatory expectations.
• Oversee planning, preparation, and delivery of high-quality CMC sections for INDs,CTAs, IMPDs, NDAs/MAAs, amendments, supplements, variations, annual reports,and responses to health authority questions.
• Evaluate complex CMC changes, including manufacturing process, analytical method,specification, stability, packaging, supplier, and manufacturing site changes,and define appropriate global regulatory reporting and submission strategies.
• Lead Regulatory CMC gap assessments of source documents, development reports,manufacturing records, validation packages, specifications, stability data, and quality documents to identify filing risks, compliance gaps, and remediation plans.
• Direct and coordinate interactions with CMOs, CDMOs, contract laboratories, consultants,and internal functions to obtain, review, and finalize CMC documentation required for regulatory submissions, commitments, and lifecycle management activities.
• Providein-depth Regulatory CMC review of manufacturing, analytical, stability,validation, and quality information to support development programs and global regulatory submissions.
• LeadCMC-related interactions with regulatory authorities, including preparation of briefing materials, meeting packages, information request responses, written commitments, and strategic negotiation positions.
• Ensure CMCsubmission content is complete, consistent, scientifically justified, and compliant with applicable ICH, FDA, EMA, NMPA, MFDS, and other global health authority expectations.
• Drive cross-functional alignment with Regulatory Affairs, Quality, Technical Operations, Supply Chain, Clinical, Commercial, and Program Management teams to identify CMC regulatory risks, develop mitigation plans, and achieve submission deliverables and timelines.
• Manage and provide oversight of Regulatory CMC contributions from external consultants and subject matter experts to support regulatory strategy, submission planning,authoring, health authority responses, inspections, audits, due diligence,…