Job Title:
Senior Director, Global Regulatory Affairs CMC – Synthetic Molecules
Location:
Indianapolis, Indiana, USA
Job ID: R-82502
Category: Research & Development
Job Type: Full-Time, Regular
Company Overview:
Eli Lilly and Company is a global leader in pharmaceutical innovation, headquartered in Indianapolis, Indiana. For over 140 years, Lilly has focused on developing life-changing medicines and making a meaningful impact in communities around the world.
Role Summary:
The Senior Director, Global Regulatory Affairs – CMC will lead regulatory strategy and execution for Lilly’s synthetic molecule portfolio, overseeing all aspects of CMC regulatory compliance for development and commercial products globally. This executive-level leader will manage a high-performing scientific regulatory team, ensuring alignment with global health authority expectations, operational excellence, and strong external influence.
Key Responsibilities:
Leadership & Talent Development
Lead, develop, and mentor a team of regulatory scientists.
Ensure effective performance management, succession planning, and training.
Drive a culture of scientific and regulatory excellence within GRA-CMC.
Technical & Regulatory Expertise
Serve as a recognized CMC regulatory expert across synthetic molecule development, manufacturing, and global submission processes.
Guide preparation and review of key CMC documentation for INDs, CTAs, MAAs, and post-approval changes.
Oversee development and implementation of strategies to meet global CMC regulatory requirements and evolving guidelines.
Operational & Project Oversight
Direct global regulatory strategies across the synthetic molecule portfolio.
Assure timely and compliant CMC submissions for new and existing products.
Maintain a high-level view of CMC project health across development phases.
Governance, Influence & Collaboration
Represent GRA-CMC in internal governance and external regulatory forums.
Shape external regulatory environment through industry engagement and policy input.
Foster strong collaboration with cross-functional partners (Quality, Manufacturing, R&D).
Process Improvement
Drive continuous improvement of regulatory systems and business processes.
Ensure adherence to the Regulatory Quality System (RQS) and best practices documentation.
Basic Qualifications:
BS, MS, or PhD in Chemistry, Biology, Engineering, or related field.
10+ years of experience in CMC development or commercial technical support.
3+ years of people leadership experience.
Deep understanding of drug substance/drug product/analytical development.
Proven experience in regulatory strategy and submissions.
Preferred Attributes:
Executive presence and proven cross-functional influence.
Strong understanding of global regulatory trends.
Demonstrated success in both development and post-approval CMC settings.
Experience interacting with global health authorities.
Compensation & Benefits:
Salary Range: $162,000 – $237,600
Bonus: Eligible for performance-based company bonus
Benefits Include:
401(k) with match, pension plan
Medical, dental, and vision insurance
Vacation and personal time off
Life insurance and EAP programs
Wellness resources and flexible spending accounts
Diversity & Inclusion at Lilly:
Lilly is an Equal Opportunity Employer committed to fostering an inclusive workplace through active support of numerous Employee Resource Groups (ERGs), such as:
PRIDE (LGBTQ+)
WILL (Women in Leadership)
OLA (Organization of Latinx at Lilly)
Veterans Leadership Network
enAble (Disability inclusion)
Black Employees at Lilly, and more.
📌 Request Workplace Accommodation for individuals needing assistance during the application process.
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