Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine
Eli Lilly and Company
August 06, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Director/Senior Director, Regulatory CMC — Regulatory CMC strategies for a gene therapy portfolio.
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.
- Serve as primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA); lead interactions, teleconferences, and meetings.
- Provide expert regulatory CMC guidance to cross-functional teams (R&D, Manufacturing, Quality, Clinical).
- Identify and assess regulatory CMC risks/opportunities; develop mitigation strategies and recommendations to senior leadership.
- Stay current with evolving global regulatory requirements and best practices for gene therapies/ATMPs.
- Lead and mentor junior regulatory CMC professionals.
- Contribute to improvement of 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 for gene/cell therapy or ATMPs.
- 5+ years global regulatory submission experience (IND/CTA, BLA/MAA) and interactions with major health authorities.
Additional Preferences:
- Knowledge of global regulatory requirements (e.g., ICH, FDA, EMA) for biologics/ATMPs.
- Strong gene therapy, manufacturing, and analytical methods understanding.
- Excellent written/verbal communication.
- Proven leadership and cross-functional collaboration skills.
- Strategic problem-solving/decision-making.
- Ability to manage multiple projects in a fast-paced environment.
- Proficiency with regulatory information management systems and Microsoft Office Suite.
Benefits:
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- If you require 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.
- Serve as primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA); lead interactions, teleconferences, and meetings.
- Provide expert regulatory CMC guidance to cross-functional teams (R&D, Manufacturing, Quality, Clinical).
- Identify and assess regulatory CMC risks/opportunities; develop mitigation strategies and recommendations to senior leadership.
- Stay current with evolving global regulatory requirements and best practices for gene therapies/ATMPs.
- Lead and mentor junior regulatory CMC professionals.
- Contribute to improvement of 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 for gene/cell therapy or ATMPs.
- 5+ years global regulatory submission experience (IND/CTA, BLA/MAA) and interactions with major health authorities.
Additional Preferences:
- Knowledge of global regulatory requirements (e.g., ICH, FDA, EMA) for biologics/ATMPs.
- Strong gene therapy, manufacturing, and analytical methods understanding.
- Excellent written/verbal communication.
- Proven leadership and cross-functional collaboration skills.
- Strategic problem-solving/decision-making.
- Ability to manage multiple projects in a fast-paced environment.
- Proficiency with regulatory information management systems and Microsoft Office Suite.
Benefits:
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions:
- If you require accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.