Senior Director, Regulatory CMC — Small Molecule Programs

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

Benefits offered by this job

401(k) eligibility

Pension

Vacation benefits

Medical, dental, vision coverage

Flexible benefits

Life insurance

Time off and leave

Well-being benefits

Job summary

Lilly’s Centessa partnership seeks a Senior Director, Regulatory CMC to lead global CMC strategies for small molecule programs, guiding drug substance, product, analytics, and manufacturing teams through development and regulatory submissions.

The role emphasizes NDA-enabling activities, cross-functional leadership, and partnership with CDMOs in a fast-paced environment. Remote US-based with travel.

Qualifications

• 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.
• 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, including INDs, 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.

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.

Skills

Leadership

Project management

Communication

Cross-functional collaboration

CDMO management

Education

Master's degree in Chemistry/Pharmaceutical Sciences

PharmD or PhD preferred

Job description

Lilly’s Centessa partnership seeks a Senior Director, Regulatory CMC to lead global CMC strategies for small molecule programs, guiding drug substance, product, analytics, and manufacturing teams through development and regulatory submissions.

The role emphasizes NDA-enabling activities, cross-functional leadership, and partnership with CDMOs in a fast-paced environment. Remote US-based with travel.