Director/Sr. Director, Regulatory CMC

Eli Lilly and Company

Director/Senior Director of Regulatory CMC at Eli Lilly leading global strategies for gene therapy programs. Ensuring compliance with health authority requirements and mentoring teams.

Posted 7/28/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $163,500 - $281,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in developing and implementing global regulatory CMC strategies for gene therapy programs, with a strong focus on regulatory submissions and compliance. Proven ability to lead cross-functional teams and mentor junior professionals while managing regulatory risks and opportunities.

Highest-signal resume keywords

Regulatory CMC ExpertiseGlobal Regulatory SubmissionsGene Therapy KnowledgeLeadership SkillsRegulatory Information Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC Strategy DevelopmentIND/CTA SubmissionBLA/MAA SubmissionRegulatory Guidelines AdherenceScientific Accuracy in DocumentationAnalytical Methods UnderstandingManufacturing Process KnowledgeRisk Assessment and MitigationCross-Functional Team CollaborationContinuous Improvement Processes

Soft Skills

Interpersonal SkillsInfluencing SkillsProject ManagementMentoring SkillsCollaboration Skills

Tools & Technologies

Regulatory Information Management SystemsMicrosoft Office Suite

Industry Keywords

Gene TherapyAdvanced Therapeutic Medicinal Products (ATMPs)BiologicsFDAEMAICHHealth AuthoritiesRegulatory SubmissionsPost-Approval SubmissionsCross-Functional Development Teams

About the role

Key responsibilities & impact

Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions
Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines
Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings
Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle
Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership
Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs)
Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement
Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates
Manage external consultants and contractors as needed to support regulatory CMC activities

Requirements

What you’ll need

Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required
5+ years of expertise in regulatory CMC for gene therapy, cell therapy, or other advanced therapeutic medicinal products (ATMPs)
5+ years of experience with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.)
In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA)
Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods
Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders
Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment
Proficiency in regulatory information management systems and Microsoft Office Suite.

Benefits

Comp & perks

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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)