Remote Senior Director, Regulatory CMC

Eli Lilly; United States; Remote; USD 176,000 - 284,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly is seeking a Senior Director, Regulatory CMC to provide strategic and operational leadership across global Regulatory CMC activities for small molecule programs. The role reports to the Executive Director, Regulatory CMC and drives regulatory readiness and submissions.

The ideal candidate has 12+ years in pharma with 5+ in Regulatory CMC, including late-stage NDA-enabling activities, and strong CDMO management experience in a fast-paced environment.

Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related field 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.
• 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.

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 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.

Skills

Regulatory CMC

Leadership

IND/NDA support

Education

Master's in Chemistry/Pharma

Job description

Lilly is seeking a Senior Director, Regulatory CMC to provide strategic and operational leadership across global Regulatory CMC activities for small molecule programs. The role reports to the Executive Director, Regulatory CMC and drives regulatory readiness and submissions.

The ideal candidate has 12+ years in pharma with 5+ in Regulatory CMC, including late-stage NDA-enabling activities, and strong CDMO management experience in a fast-paced environment.