Senior Director, Regulatory 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 CMC based in the United States. We are seeking an accomplished Senior Director, Regulatory CMC to lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy across a portfolio of small-molecule drug development programs. In this senior leadership role, you will guide regulatory activities from early development through late-stage clinical programs and marketing application submissions. You will serve as a strategic partner to cross-functional teams, ensuring that drug substance, drug product, analytical development, manufacturing, and quality strategies align with global regulatory expectations. You will play a critical role in preparing regulatory submissions, managing health authority interactions, and ensuring readiness for future commercialization. Working in a fast-paced, innovation-driven pharmaceutical environment, you will oversee external development and manufacturing partners while driving regulatory excellence, risk management, and operational execution. This remote opportunity is suited to a highly experienced regulatory professional with a strong track record in NDA-enabling activities and the ability to influence complex development decisions. Accountabilities - Global Regulatory CMC Strategy: Develop and execute integrated regulatory strategies for small-molecule programs, supporting development from preclinical stages through late-stage clinical development, marketing applications, and lifecycle management. - Late-Stage Development and Registration: Lead regulatory CMC activities for advanced development programs, including NDA-enabling work, marketing application preparation, and strategies to support successful product registration.

- Technical and Scientific Leadership: Provide strategic guidance across drug substance, drug product, analytical development, manufacturing processes, specifications, and control strategies to ensure robust development and regulatory readiness. - Cross-Functional Collaboration: Serve as the Regulatory CMC subject matter expert on program teams, aligning CMC development plans with clinical, regulatory, quality, manufacturing, and business objectives. - Regulatory Submission Management: Lead the preparation, review, and approval of CMC documentation for global regulatory submissions, including INDs, CTAs, IMPDs, NDAs, supplements, variations, briefing packages, and responses to health authority questions. - Health Authority Engagement: Provide expert input into regulatory interactions, interpret agency feedback, and develop scientifically sound responses that support development milestones and registration objectives. - Regulatory Intelligence: Monitor evolving global regulatory requirements, FDA and EMA guidance, ICH standards, and relevant regulatory precedents, incorporating new insights into development and submission strategies. - External Partner Management: Oversee contract development and manufacturing organizations (CDMOs) and other external partners, including partner selection, performance management, technology transfer, process scale-up, validation, and manufacturing readiness. - Quality and Compliance: Ensure that development and manufacturing activities align with applicable global regulatory requirements, current Good Manufacturing Practices (cGMP), and relevant quality standards. - Inspection and Supply Readiness: Support regulatory inspection readiness and clinical supply continuity by identifying potential risks, strengthening documentation, and coordinating mitigation activities with internal and external stakeholders. - Project and Resource Management: Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies to ensure efficient execution of regulatory CMC activities.