Job Title
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology
Location
Indianapolis, Indiana, United States
Company
Eli Lilly and Company
Category
Research & Development
Job Type
Full Time | Regular
Job ID
R-83972
Position Summary
Eli Lilly is looking for a Senior Director to serve as the Global Regulatory Lead (GRL) for Neuroscience/Immunology. The GRL will be responsible for developing and implementing global regulatory strategies from portfolio entry through the end of the product lifecycle. The role involves leading the Global Regulatory Team (GRA), engaging with regulatory agencies, managing risks, and ensuring alignment of local strategies to global objectives. This position also involves developing regulatory strategies for preclinical and early clinical development programs, including leading U.S. and Canadian submissions.
Key Responsibilities
Regulatory and Scientific Expertise:
Develop, update, and execute the Global Regulatory Strategy (GRS).
Lead the Global Regulatory Team to create and maintain Regulatory Strategy Documents (RSD).
Ensure strategies are aligned with global and regional business objectives, product labeling, and risk management.
Represent GRA on the Global Brand Development (GBD)/global program team.
Lead regulatory strategies for preclinical and early clinical development programs.
Team Leadership:
Lead and develop a team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications.
Foster clear communication between the GBD/global program team and the Global Regulatory Team.
Coach and facilitate feedback culture within the team to ensure performance and effective regulatory strategy execution.
Agency Interactions and Submissions:
Own relationships and strategy with FDA and Health Canada.
Lead the development of regulatory submissions and ensure the regulatory documents meet expectations.
Propose innovative solutions to regulatory challenges and ensure compliance with internal quality systems.
Cross-Functional Representation:
Represent regulatory interests on cross-functional teams, ensuring alignment with strategic planning, trial design, and registration strategies.
Engage in shaping the external regulatory environment by building strategic relationships with key external players.
Education Requirements
Advanced scientific degree (PhD, PharmD) with 8+ years of industry-related experience in regulatory affairs or drug development.
OR a Bachelor's degree with 10+ years of experience in regulatory affairs or drug development.
Additional Skills/Preferences
Proven experience in regulatory submissions in US, EU, China, and Japan.
Strong knowledge of global regulatory procedures and evolving regulatory reform initiatives.
Experience in neuroscience or immunology therapeutic areas.
Strong written, spoken, and presentation communication skills.
Compensation
Anticipated Salary Range: $162,000 – $237,600 annually.
Eligible for company bonus program (based on company and individual performance).
Benefits
401(k) plan and pension
Vacation and paid time off
Medical, dental, vision, and prescription drug benefits
Flexible spending accounts (healthcare, dependent care)
Life insurance and death benefits
Wellness programs (EAP, fitness benefits, clubs and activities)
Other leave of absence benefits
Travel
10-15% travel required.
On-Site Position
Located at Lilly Corporate Center in Indianapolis, Indiana.
Equal Opportunity Employer
Lilly is an equal opportunity employer dedicated to diversity and inclusion.
Employee Resource Groups (ERGs)
Includes groups such as Black Employees at Lilly, Organization of Latinx at Lilly (OLA), Lilly India Network, PRIDE (LGBTQ+ Allies), Women’s Initiative for Leading at Lilly (WILL), and others.
Accommodation
Applicants needing accommodations during the application process can request assistance via the Accommodation Request Form.
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