Regulatory Delivery Excellence, Global Submission Publisher

Eli Lilly and Company

GRA Regulatory Delivery Excellence role at Lilly creating and maintaining regulatory registrations. Managing submissions for compliance while ensuring timely review by regulatory agencies.

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance within the pharmaceutical industry, with a strong focus on eCTD structure, global health authority regulations, and document management systems. Proficient in optimizing business processes to ensure timely and quality submissions across multiple markets.

Highest-signal resume keywords

Regulatory Submissions ManagementECTD Compliance ExpertiseRegulatory Information Management Systems (RIM)Global Health Authority RegulationsDocument Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Operations ExperienceCTD/eCTD Structure KnowledgeSubmission Formatting and PublishingDrug Development Process KnowledgeSubmission Cover Letter Preparation

Soft Skills

CommunicationCoordinationCollaboration

Tools & Technologies

ECTDXpressVeeva PlatformsMS-Office SuiteAdobe Acrobat

Industry Keywords

Pharmaceutical RegulatoryICH RegulationsCBER/CDER Requirements30-Day Packet ComplianceMed Watch Submissions

About the role

Key responsibilities & impact

create and maintain regulatory registrations from candidate selection through end of product lifecycle
create global registrations and provide maintenance support as needed for major markets
meet customer requirements by optimizing business processes, tools and ensuring implementation of the regulatory agency’s preferred eCTD specifications in a quality way to promote timely review by the regulatory agency
build eCTD expertise and partner with Regulatory Associates, Regulatory Scientists, other publishing centers, vendors, and/or other contributing areas
manage multiple submission types across assigned molecules
coordinate and communicate with Regulatory Associates to execute planned compliance and strategic submissions
review and monitor the RIM or Share Point Calendar for delivery of planned documents in support of submissions
prepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review and approval
create different dossiers for Europe, the U.S., Canada, or other supported worldwide markets
ensure compliance with 30-Day Packet and Med Watch submissions
manage FDA Web trader account to enable submissions via electronic gateway
oversee the creation and management of submission publishing training materials

Requirements

What you’ll need

H.S. diploma AND
5+ years of Pharmaceutical Regulatory industry experience
Qualified applicants must be authorized to work in the United States on a full-time basis
BS Degree in life science or computer science preferred
Knowledge of drug development process
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 with experience and knowledge in formatting and publishing medium/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical)
Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure
Current knowledge of CBER/CDER regulatory technical requirements
Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness
Experience with document management and Regulatory Information Management Systems (RIM)

Benefits

Comp & perks

company bonus
comprehensive benefit program
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)