Regulatory Delivery Excellence, Global Submission Publisher

🕒 5 days ago

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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 electronic common technical document (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 to align on submission specific requirements • Manage multiple submission types across assigned molecules and communicate with Regulatory Associates to execute planned compliance and strategic submissions • Review and monitor the RIM or Share Point Calendar for planned documents supporting submissions

🎯 Requirements

• 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

• Comprehensive benefit program including eligibility for medical, dental, vision, and prescription drug benefits • Eligibility to participate in a company-sponsored 401(k) • Pension • Vacation 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)