Remote Senior Director, Regulatory CMC — Small Molecules

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

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision coverage

Flexible benefits

Life insurance

Time off and leave

Job summary

Eli Lilly and Company is seeking a Senior Director, Regulatory CMC, to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs. You will lead regulatory initiatives, partner with internal and external stakeholders, and oversee submissions globally.

The ideal candidate brings 12+ years in pharma with deep Regulatory CMC experience, including NDA-enabling activities, and strong CMOs management.

Qualifications

• Minimum 12 years in pharma, with at least 5 in Regulatory CMC.
• Recent experience leading Regulatory CMC for late-stage programs, NDA-enabling activities.
• Proven authoring/management of INDs, IMPDs, NDAs, and global health authority interactions.
• Strong knowledge of small molecule drug substance/product development, analytics, and manufacturing.
• Experience managing CDMOs and external development/manufacturing organizations.

Responsibilities

• Lead the development and execution of Regulatory CMC strategies across small molecule programs.
• Provide strategic and technical leadership for drug substance, drug product, analytics, manufacturing and control.
• Serve as CMC SME on cross-functional teams, aligning development plans with clinical and regulatory objectives.
• Guide regulatory risk assessment, lifecycle management, and health authority expectations.
• Lead the preparation, review, and approval of CMC content for global submissions (INDs, NDAs, variations).
• Monitor evolving regulatory requirements and incorporate innovative approaches.
• Manage external partners and technology transfer activities; ensure manufacturing readiness.
• Ensure compliance with FDA, EMA, ICH, and cGMP requirements; support inspections.
• Develop project plans, timelines, budgets, and risk mitigation with stakeholders.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory strategy

IND/NDAs

CDMO management

cGMP knowledge

ICH guidelines

FDA regulations

Orexin/CNS

Education

Master's in Chemistry/Pharmaceutical Sciences

PharmD or PhD preferred

Job description

Eli Lilly and Company is seeking a Senior Director, Regulatory CMC, to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs. You will lead regulatory initiatives, partner with internal and external stakeholders, and oversee submissions globally.

The ideal candidate brings 12+ years in pharma with deep Regulatory CMC experience, including NDA-enabling activities, and strong CMOs management.