Eli Lilly and Company · 16 hours ago
Associate/Sr. Associate/Manager - Global Regulatory Affairs (GRA) Regulatory Delivery & Excellence (RD&E)
United States
Full-time
Remote
Entry, Mid Level
$63K/yr - $150K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Global Regulatory Associate to manage operational and technical registration processes, ensuring compliance and effective delivery of products to patients worldwide.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level. This includes but is not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD. This role may act to produce and submit eCTD submissions globally or regionally
Ensure incoming correspondence are archived accurately and related to appropriate records, assuring all metadata fields are complete in RIM
Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content in support of non-eCTD submissions in line with local agency regulations and requirements as needed. For example, utilize approved submission requirements provided in Regulatory systems to create submissions through the use of RIM technology allowing this role to lead the planning and execution for non-eCTD submissions and also drive any new electronic submissions in those regions who have and are adopting the eCTD specification
Support Affiliate Regulatory/Alliance Managers with RIM content planning for IND, MAA, Line extensions and new indication submission types
Create global and where appropriate regional content plans matching appropriate documents to support submission strategies defined by global regulatory strategy scientist or Regional/Affiliate Regulatory staff
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 to ensure all required electronic records are timely, complete, and accurate. Records include IND and MAA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact
Serve as the RD&E operational lead for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RD&E planning
Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions)
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
Provide registration management expertise to the due diligence and business development processes
Serve as the registration management expert for other processes dependent upon the registration record (e.g. OSI requests, out-license, user fees/drug listing/orange book)
Partner with Regulatory Policy to identify areas of desired change in the external environment
Take advantage of evolving technology and regulatory requirements to identify and seek opportunities for novel submission processes (eg. Cloud-based submissions)
Develop collaborative relationships with personnel in other Lilly functional areas (e.g. medical, legal, labeling, compliance, quality, affiliates, etc.) to effectively influence the electronic registration plan
Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions
As directed by leadership, develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) and applicable regulators in other countries to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review
Partner with the Affiliate/Regional Regulatory Staff to plan, facilitate and document internal, regulator, and partner meetings
Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise
Influence others in a manner that creates maximum advantage for the organization
Communicate verbally and in writing to effectively influence within work group/function and with development team
Serve as a mentor within GRA and SME for RD&E processes
Qualification
Required
BS in a technical or scientific discipline (such as chemistry, biology, pharmacy)
2+ years of experience with drug development process
Preferred
Quick learning agility, retention of knowledge, strong project management skills, flexibility, organizational skills, and fast adoption of new technology solutions are very important for success in this role
Previous project management and global submission experience
Knowledge of drug development process, Lilly regulatory/business strategies and plans
Demonstrated ability operate and manage operational requirements in a highly regulated environment
Demonstrated effective written, spoken and presentation skills
Demonstrated effective negotiation and influence skills
Demonstrated attention to detail
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Benefits
Company bonus (depending, in part, on company and individual performance)
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)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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