Clinical Regulatory Associate, GRA Regulatory Delivery Excellence

Eli Lilly and Company

Global Clinical Regulatory Associate supporting regulatory delivery excellence at Lilly. Specializing in operational registration management, compliance and leading submissions across complex projects in pharmaceutical sector.

Posted 7/28/2026full-timeIndianapolis • 🇺🇸 United StatesJuniorMid-Level💰 $63,000 - $149,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in registration management processes, including electronic submission regulations and compliance within the pharmaceutical industry. Proficient in project management and collaboration with cross-functional teams to ensure adherence to global health authority and ICH regulations.

Highest-signal resume keywords

Regulatory Operations ExperienceProject Management ExperienceKnowledge of Drug Development ProcessExperience with eCTD SubmissionsStrong Knowledge of ICH Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ManagementECTD SubmissionIND SubmissionNDA SubmissionProject ManagementDrug Development KnowledgeCompliance ProcessesRegistration PlanningLifecycle SubmissionsDue Diligence Processes

Tools & Technologies

ECTDXpressVeeva Platforms

Industry Keywords

Pharmaceutical IndustryGlobal Health Authority RegulationsICH RegulationsElectronic Submission RegulationsRegistration Management

About the role

Key responsibilities & impact

Lead the registration management process by providing expertise in electronic submission regulations and guidance
Partner with other geographies to understand and incorporate local agency regulations and requirements
Guide and influence development team and function regarding internal and Agency registration management processes and requirements
Own the registration management process at the molecule/project level
Serve as the RDE operational lead for registration planning and execution
Own the routine compliance submissions and processes
Partner with the Regulatory Coordinator/Scientist to drive execution of the product deletion, IND inactivation/withdrawal process
Provide registration management expertise to due diligence processes

Requirements

What you’ll need

BS or higher degree in a technical field such as chemistry, biology, pharmacy or life sciences
Qualified applicants must be authorized to work in the United States on a full-time basis
Knowledge of drug development process
Project Management Experience
Previous experience working in the Pharmaceutical industry
Experience with CTD/eCTD structure and format
Experience using eCTD compliant publishing system (eCTDXpress or Veeva based platforms)
Three years of regulatory operations experience within a regulated environment
Experience with Original IND and supplemental NDA/BLA eCTD submissions including complex lifecycle submissions
Strong knowledge of global health authority and ICH regulations

Benefits

Comp & perks

Comprehensive benefit program including medical, dental, vision, and prescription drug benefits
Pension and 401(k)
Paid vacation benefits
Flexible spending accounts for healthcare and dependent care
Life insurance and death benefits
Employee assistance program and well-being benefits