Director, Regulatory CMC Strategy

About the role

The Director, Regulatory CMC will provide strategic and operational support for Regulatory CMC activities across the company's small molecule development programs. Reporting to the Executive Director, Regulatory CMC, this individual will develop and execute global CMC regulatory strategies, partner with internal and external stakeholders, and oversee CMC regulatory submissions across our portfolio.

Responsibilities

• Develop and execute integrated Regulatory CMC strategies supporting small molecule programs from preclinical development through late-stage clinical development and regulatory submissions.
• Provide strategic and technical support across drug substance, drug product, analytical development, manufacturing, and control activities to support clinical development, regulatory submissions, and future commercialization.
• Serve as the Regulatory CMC subject matter expert on cross-functional program teams, ensuring alignment of CMC development plans with clinical, regulatory, quality, and business objectives.
• Provide strategic regulatory guidance to CMC and program teams, driving informed decision-making related to development plans, regulatory risk assessment, future lifecycle management, and health authority expectations.
• Lead the preparation, review, and approval of CMC content for global regulatory submissions and responses, including INDs, CTAs, marketing applications, supplements/variations, briefing packages, and health authority information requests.
• Monitor and interpret evolving global regulatory requirements, guidance, and precedent, incorporating innovative regulatory approaches to support efficient product development and registration strategies.
• Liaise with external development and manufacturing partners, including CDMO oversight, performance management, technology transfer, scale-up, validation, and manufacturing readiness activities.
• Ensure compliance with applicable global regulatory requirements, including FDA, EMA, ICH, and cGMP expectations, while supporting inspection readiness and supply continuity.
• Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies while building effective partnerships with internal stakeholders and external collaborators.
• Build effective relationships with internal stakeholders and external partners to support program advancement and organizational goals.

Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; PharmD or PhD preferred.
• 8+ years of pharmaceutical industry experience, including at least 5 years in Regulatory CMC roles supporting small molecule development programs.
• Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions, is required.
• Proven experience authoring, reviewing, and managing CMC regulatory filings, including INDs, IMPDs, NDAs, and global health authority interactions.
• Strong knowledge of small molecule drug substance and drug product development, analytical development, manufacturing processes, control strategies, and pharmaceutical development principles.
• Extensive experience managing CDMOs and external development and manufacturing organizations.
• Thorough understanding of cGMP requirements, ICH guidelines, FDA regulations, and global Regulatory CMC expectations.
• Demonstrated experience supporting programs from early development through IND submission and lifecycle management.
• Experience supporting technology transfer, process development, scale-up, validation, and clinical supply manufacturing activities.
• Excellent leadership, project management, communication, and cross-functional collaboration skills.
• Experience in orexin, CNS, or other specialty therapeutic areas is preferred.