Eli Lilly and Company

Associate/Sr. Associate/Manager – Global Regulatory Affairs, Regulatory Delivery & Excellence

Eli Lilly and Company

full-time

Posted on:

Location Type: Hybrid

Location: Indianapolis • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $63,000 - $149,600 per year

Job Level

Senior

About the role

  • Provide Regulatory, Submission Planning and Execution Expertise
  • Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level
  • Ensure compliance with all applicable regulations and internal quality systems
  • Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content
  • Support Affiliate Regulatory/Alliance Managers with RIM content planning for IND, MAA, Line extensions and new indication submission types
  • Own the registration management process at the molecule/project level
  • Serve as the RD&E operational lead for registration planning and execution
  • Partner with the Global Regulatory Strategy Scientist/Regional/Affiliate Regulatory Staff to drive the execution of product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process

Requirements

  • BS in a technical or scientific discipline (such as chemistry, biology, pharmacy)
  • 2+ years of experience with drug development process
  • Qualified applicants must be authorized to work in the United States on a full-time basis
Benefits
  • Comprehensive benefit program
  • 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)
  • Company-sponsored 401(k)
  • Pension
  • Vacation benefits
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory expertisesubmission planningelectronic submission regulationsregistration managementRIM content planningIND submissionMAA submissionproduct withdrawal processdrug development process
Soft Skills
leadershipcollaborationcommunication