Director, Regulatory CMC Strategy

BioSpace; Indiana (PA); On-site; USD 150,000 - 242,000; Full time

Benefits offered by this job

Bonus eligible

Comprehensive benefits

401(k) and pension

Job summary

Lilly, headquartered in Indianapolis, IN, seeks a Director of Regulatory CMC to lead global regulatory strategies for small molecules, from early development through NDA submissions. You will guide drug substance/product development, interact with CDMOs, and ensure readiness for inspections and health authority interactions.

Ideal candidates have 8+ years in pharma, with 5+ in Regulatory CMC and proven NDA-enabling experience.

Qualifications

• 8+ years of pharmaceutical industry experience with at least 5 years in Regulatory CMC.
• Experience leading NDA-enabling activities for late-stage programs.
• Experience authoring and managing CMC filings (INDs, NDAs) across development to submission.

Responsibilities

• Develop and execute integrated Regulatory CMC strategies for small molecule programs from preclinical through regulatory submissions.
• Provide strategic and technical support across drug substance, drug product, analytical development, manufacturing, and controls.
• Serve as the Regulatory CMC SME on cross-functional program teams and align development plans with objectives.
• Provide regulatory guidance to CMC and program teams to support lifecycle management and health authority expectations.
• Lead preparation, review, and approval of CMC content for global submissions and responses (INDs, CTAs, NDAs).
• Monitor evolving global regulatory requirements and adapt strategies accordingly.
• Liaise with CDMOs and external partners, oversee tech transfer, scale-up, validation, and readiness.
• Ensure compliance with FDA/EMA/ICH/cGMP and inspection readiness.

Skills

Regulatory CMC leadership

Project management

Cross-functional collaboration

Regulatory submissions

CDMO management

FDA/ICH knowledge

Education

Master's degree in Chemistry/Pharmaceutical Sciences

PharmD or PhD preferred

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Position Summary

The Director, Regulatory CMC will provide strategic and operational support for Regulatory CMC activities across the company's small molecule development programs. Reporting to the Executive Director, Regulatory CMC, this individual will develop and execute global CMC regulatory strategies, partner with internal and external stakeholders, and oversee CMC regulatory submissions across our portfolio. The ideal candidate brings experience supporting global small molecule programs from early development through regulatory submission, including IND- and NDA-supporting activities. While broad lifecycle experience is highly desirable, recent, hands-on leadership of late-stage development programs, NDA-enabling activities, and marketing application submissions is required. The successful candidate will have strong expertise in outsourced development and manufacturing and a proven ability to drive regulatory readiness and execution in a fast-paced environment.

Key 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 support 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.
• Liaise with external development and manufacturing partners, including CDMO 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.

Required Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; PharmD or PhD preferred.
• 8+ 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.

Compensation

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $150,000 - $242,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly