Remote Senior Director, Regulatory CMC – Small Molecules

Eli Lilly and Company; Boston (MA); Remote; USD 176,000 - 284,000; Full time

Job summary

Eli Lilly and Company is seeking a Senior Director, Regulatory CMC to lead strategic and operational regulatory CMC activities across small molecule programs. You will guide CMC development plans and submissions, partnering with internal teams and external partners to ensure readiness and timely regulatory approvals.

The role requires 12+ years in pharma with 5+ in Regulatory CMC, strong leadership, and experience with NDA-enabling activities.

Qualifications

• Master's degree required; PharmD or PhD preferred.
• Minimum 12 years of pharmaceutical industry experience, including at least 5 years in Regulatory CMC.
• Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities.
• Proven experience authoring, reviewing, and managing CMC regulatory filings (INDs, NDAs, global health authority interactions).
• Strong knowledge of small molecule drug substance/product development, analytical development, and manufacturing.
• Extensive experience managing CDMOs and external development/manufacturing organizations.
• Thorough understanding of cGMP, ICH, FDA regulations, and global Regulatory CMC expectations.

Responsibilities

• Develop and execute integrated Regulatory CMC strategies from preclinical through late-stage development and submissions.
• Provide strategic and technical leadership across drug substance, product, analytical development, manufacturing, and control activities.
• Serve as the Regulatory CMC SME on cross-functional program teams.
• Provide regulatory guidance to CMC and program teams for decision-making and lifecycle management.
• Lead preparation, review, and approval of CMC content for INDs, NDAs, and global submissions.
• Monitor evolving global regulatory requirements and incorporate innovative approaches to support development and registration.
• Manage external CDMOs including selection, oversight, tech transfer, scale-up, and manufacturing readiness.
• Ensure compliance with global regulatory requirements, including FDA/EMA/ICH/cGMP and inspection readiness.
• Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation; build partnerships with internal/external stakeholders.
• Build relationships with internal stakeholders and external partners to advance programs.

Skills

Leadership

Project management

Communication

Cross-functional collaboration

Regulatory CMC

Education

Master's degree in Chemistry or Pharmaceutical Sciences

PharmD or PhD preferred

Job description

Eli Lilly and Company is seeking a Senior Director, Regulatory CMC to lead strategic and operational regulatory CMC activities across small molecule programs. You will guide CMC development plans and submissions, partnering with internal teams and external partners to ensure readiness and timely regulatory approvals.

The role requires 12+ years in pharma with 5+ in Regulatory CMC, strong leadership, and experience with NDA-enabling activities.