Instagram
youtube
Facebook

Senior Director, Global Regulatory Affairs Cmc – Synthetic Molecules

10+ years
$162,000 – $237,600
10 June 4, 2025
Job Description
Job Type: Full Time Education: BS, MS, or PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.