Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine
Eli Lilly and Company
August 06, 2026
Remote friendly (Indiana, United States)
United States
Corporate Functions
Director/Senior Director, Regulatory CMC — Gene Therapy
Job Responsibilities:
- Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs (IND/CTA, BLA/MAA, and post-approval submissions).
- Lead and manage preparation, authoring, and review of high-quality CMC sections for regulatory submissions, ensuring scientific accuracy, clarity, and guideline adherence.
- Serve as primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) and lead/facilitate interactions, teleconferences, and meetings.
- Provide expert regulatory CMC guidance to cross-functional teams (R&D, Manufacturing, Quality, Clinical) across the product lifecycle.
- Identify and assess regulatory CMC risks/opportunities; develop mitigation strategies and recommend actions to senior leadership.
- Stay current with evolving global regulatory requirements and best practices for gene therapies/ATMPs.
- Lead and mentor junior regulatory CMC professionals.
- Improve internal regulatory CMC processes, standards, and templates.
- Manage external consultants/contractors as needed.
Minimum Requirements:
- Bachelor’s degree in a scientific discipline; MS/Ph.D. strongly preferred.
- 5+ years regulatory CMC experience in gene/cell therapy or ATMPs.
- 5+ years experience with global regulatory submissions (IND/CTA, BLA/MAA) and interactions with major health authorities.
Additional Preferences (desired):
- Knowledge of global biologics/ATMP guidance (ICH, FDA, EMA).
- Strong understanding of gene therapy technologies, manufacturing, and analytical methods.
- Excellent written/verbal communication.
- Leadership/interpersonal skills and ability to influence cross-functional/external stakeholders.
- Strategic problem-solving and decision-making; multitask in fast-paced environment.
- Proficiency with regulatory information systems and Microsoft Office.
Compensation/Benefits (if applicable): $163,500–$281,600 plus potential company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off/leave, well-being benefits).
Application instructions: If you need an accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.
Job Responsibilities:
- Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs (IND/CTA, BLA/MAA, and post-approval submissions).
- Lead and manage preparation, authoring, and review of high-quality CMC sections for regulatory submissions, ensuring scientific accuracy, clarity, and guideline adherence.
- Serve as primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) and lead/facilitate interactions, teleconferences, and meetings.
- Provide expert regulatory CMC guidance to cross-functional teams (R&D, Manufacturing, Quality, Clinical) across the product lifecycle.
- Identify and assess regulatory CMC risks/opportunities; develop mitigation strategies and recommend actions to senior leadership.
- Stay current with evolving global regulatory requirements and best practices for gene therapies/ATMPs.
- Lead and mentor junior regulatory CMC professionals.
- Improve internal regulatory CMC processes, standards, and templates.
- Manage external consultants/contractors as needed.
Minimum Requirements:
- Bachelor’s degree in a scientific discipline; MS/Ph.D. strongly preferred.
- 5+ years regulatory CMC experience in gene/cell therapy or ATMPs.
- 5+ years experience with global regulatory submissions (IND/CTA, BLA/MAA) and interactions with major health authorities.
Additional Preferences (desired):
- Knowledge of global biologics/ATMP guidance (ICH, FDA, EMA).
- Strong understanding of gene therapy technologies, manufacturing, and analytical methods.
- Excellent written/verbal communication.
- Leadership/interpersonal skills and ability to influence cross-functional/external stakeholders.
- Strategic problem-solving and decision-making; multitask in fast-paced environment.
- Proficiency with regulatory information systems and Microsoft Office.
Compensation/Benefits (if applicable): $163,500–$281,600 plus potential company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off/leave, well-being benefits).
Application instructions: If you need an accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.