Senior Director, Regulatory CMC

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.

• 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.
• Risk Assessment and Decision Support:
  Evaluate regulatory…