Eli Lilly and Company · 7 hours ago
Director, CMC Regulatory
Philadelphia, PA
Full-time
Onsite
Director/Executive
$148K/yr - $218K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Director, CMC Regulatory will utilize their expertise to drive global regulatory CMC strategies for diagnostic radiopharmaceutical products, overseeing submissions and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Responsible for the generation and execution of country specific CMC regulatory strategies for investigational and commercial radiopharmaceutical products
Lead global CMC regulatory submissions including authoring, review, and finalization
Lead and contribute to responses to regulatory agency questions globally
Review change controls to assess country-specific CMC regulatory impact
Review technical documents including testing protocols, technical reports, and CMO procedures and specifications from a CMC regulatory perspective
Demonstrate an in-depth understanding of CMC regulatory requirements across multiple regions
Monitor and evaluate new regulations / guidance, regulatory changes / trends pertaining to CMC regulatory and communicate with internal stakeholders
Managing small group of CMC regulatory professionals
Perform other duties as assigned
Qualification
Required
BS Degree in science, engineering, or a related field
Minimum of 10 years in pharmaceutical drug development and/or pharmaceutical manufacturing with a minimum of five years of direct CMC regulatory experience
Preferred
Advanced degree strongly preferred
PET drug experience preferred
Ability to manage people and drive engagement among teams
Demonstrated strong written, spoken and presentation communication skills
Excellent technical writing skills
Ability to plan and align
Ability to adapt to change and be a nimble learner
Ability to ensure accountability of oneself and others
Demonstrated leadership behaviors and negotiation and influence skills
Creative thinking and ability to cultivate innovation
Demonstrated attention to detail
Excellent MS Office skills
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
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
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
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
The Motley Fool
2026-01-25
2026-01-24
2026-01-23
Company data provided by crunchbase