Senior Director, Regulatory Affairs, CMC

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Director, Regulatory Affairs, CMC based in the United States. As Senior Director, Regulatory Affairs, CMC, you will lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for an innovative oncology portfolio, with a particular focus on antibody-drug conjugates (ADCs). You will serve as the Global Regulatory Lead for a late-stage program progressing toward Biologics License Application (BLA) submission, overseeing regulatory planning, execution, and health authority interactions. This strategic leadership role combines scientific expertise, regulatory excellence, and people management to advance complex therapies through development, registration, commercialization, and lifecycle management. You will lead a U. S. -based team while coordinating with global, cross-functional stakeholders across manufacturing, quality, supply chain, clinical development, and regulatory affairs. By anticipating regulatory risks and ensuring high-quality submissions, you will help accelerate development timelines and maintain compliance across a dynamic product portfolio. This is an opportunity to influence global regulatory strategy and contribute to making innovative cancer treatments more accessible to patients worldwide. Accountabilities - Lead Regulatory CMC strategy: Direct the development and execution of global CMC regulatory strategies for the ADC portfolio throughout development, registration, commercialization, and lifecycle management. - Oversee global regulatory leadership: Serve as the Global Regulatory Lead for a late-stage ADC program approaching BLA submission, coordinating regional regulatory team members and ensuring alignment on global strategy, priorities, and deliverables.

- Manage regulatory submissions: Lead the preparation, review, finalization, and maintenance of CMC regulatory dossiers, ensuring submissions and responses meet applicable regulatory requirements and established timelines. - Coordinate health authority interactions: Lead regulatory engagement and responses to health authority questions, ensuring clear, scientifically sound, and strategically aligned communications. - Build and develop the team: Lead and mentor a U. S. -based Regulatory CMC team of approximately five professionals, fostering technical excellence, accountability, collaboration, and professional development. - Drive cross-functional collaboration: Partner with CMC, Manufacturing, Quality, Supply Chain, Clinical, and Global Regulatory Affairs teams to align regulatory strategies with product development plans and business objectives. - Manage regulatory changes: Oversee CMC change-control impact assessments and determine appropriate regulatory pathways, filing requirements, and implementation timelines. - Identify and mitigate regulatory risks: Proactively assess regulatory risks across the ADC portfolio, develop mitigation plans, and escalate significant issues to senior leadership when necessary. - Maintain regulatory compliance: Establish and continuously improve standard operating procedures, work instructions, and best practices to promote consistency, compliance, and inspection readiness. - Support product quality and lifecycle management: Guide regulatory assessments and strategies related to product quality issues, deviations, complaints, recalls, and other post-approval or lifecycle matters. - Review and approve documentation: Ensure the quality, accuracy, and regulatory compliance of CMC submissions, responses, internal procedures, and relevant records maintained in the Regulatory Information Management (RIM) system. - Support business development: Lead or oversee Regulatory CMC due diligence for licensing, acquisitions, and other strategic opportunities, identifying regulatory gaps, risks, and potential impacts.