Director/Sr. Director, Regulatory CMC – Lilly Gene Therapy
Eli Lilly and Company
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $163,500 - $281,600 per year
Job Level
About the role
- 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
- Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA)
- Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical)
- Proactively identify and assess regulatory CMC risks and opportunities
- 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
- 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
- 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
- Excellent written and verbal communication skills
- Proven leadership and interpersonal skills
- Strategic thinker with strong problem-solving and decision-making abilities
- Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment
- Proficiency in regulatory information management systems and Microsoft Office Suite
Benefits
- 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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory CMCIND/CTA submissionsBLA/MAA submissionsgene therapycell therapyadvanced therapeutic medicinal products (ATMPs)global regulatory requirementsanalytical methodsmanufacturing processesregulatory information management systems
Soft Skills
written communicationverbal communicationleadershipinterpersonal skillsstrategic thinkingproblem-solvingdecision-makingproject managementmentoringcollaboration