Regulatory CMC Senior Director – Small Molecules

Lilly; Boston (MA); A distancia; USD 176.000 - 284.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) matching

Pension

Health, dental, vision benefits

Well-being programs

Descripción de la vacante

Lilly is seeking a Senior Director, Regulatory CMC to provide strategic and operational leadership across regulatory CMC activities for small molecule programs. You will guide drug substance and product development, analytical development, and manufacturing, with a focus on NDA-enabling activities and global submissions.

The role requires leading cross-functional teams, liaising with health authorities, and ensuring compliance with FDA, EMA, ICH, and cGMP standards in a fast-paced environment.

Formación

• Master’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; PharmD or PhD preferred.
• Minimum of 12 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.

Responsabilidades

• 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 leadership 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.
• Manage external development and manufacturing partners, including CDMO selection, 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.

Conocimientos

Leadership

Project management

Communication

Cross-functional collaboration

Educación

Master's degree in Chemistry/Pharmaceutical Sciences

PharmD or PhD preferred

Descripción del empleo

Lilly is seeking a Senior Director, Regulatory CMC to provide strategic and operational leadership across regulatory CMC activities for small molecule programs. You will guide drug substance and product development, analytical development, and manufacturing, with a focus on NDA-enabling activities and global submissions.

The role requires leading cross-functional teams, liaising with health authorities, and ensuring compliance with FDA, EMA, ICH, and cGMP standards in a fast-paced environment.