Eli Lilly and Company · 6 days ago
Director/Sr. Director Regulatory CMC, Lilly Gene Therapy
Boston, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$164K/yr - $282K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for their gene therapy portfolio, ensuring compliance with global health authority requirements.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
Education: Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required. An advanced degree (MS, Ph.D.) is strongly preferred
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.)
Preferred
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, with the ability to articulate complex scientific and regulatory concepts clearly and concisely
Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders
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
Company bonus
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
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2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-23
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