Eli Lilly

Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

Eli Lilly$169K — $248K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Advanced degree (PharmD/PhD) plus 8+ years in regulatory affairs/drug development or a Bachelor's/Master's with 10+ years in the same fields
  • In-depth knowledge of global regulatory procedures
  • Experience with regulatory submissions and interactions in US, EU, China, Japan
  • Knowledge in both clinical and CMC regulatory sciences
  • Strong leadership, negotiation, and communication skills at executive levels
  • Capable of risk assessment and management in regulated environments
  • Experience in relevant therapeutic areas

Responsibilities

  • Develop and execute global regulatory strategies from candidate selection to end-of-lifecycle
  • Integrate competitive insights and health authority guidance into regulatory strategies
  • Represent regulatory affairs on the Global Brand Development team to navigate regulatory challenges
  • Ensure local regulatory plans reflect global strategy and business needs
  • Oversee all US FDA submissions and maintain agency relationships
  • Conduct high-quality communications with the FDA regarding scientific positions
  • Lead a cross-functional Global Regulatory Team and mentor team members
  • Establish relationships with external stakeholders to influence regulatory environments

Benefits

  • Participation in a company-sponsored 401(k) and pension
  • Vacation benefits
  • Medical, dental, vision, and prescription drug coverage
  • Flexible spending accounts for healthcare and dependent care
  • Life insurance and death benefits
  • Variety of leave and time-off benefits
  • Well-being programs, including employee assistance and fitness benefits
Full Job Description
About the Role

As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies- from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team , serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.

Key Responsibilities

Regulatory Strategy
  • Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle
  • Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice to drive robust, forward-looking strategies
  • Lead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriers
  • Ensure local affiliate regulatory plans align to global strategy and business priorities - spanning labeling, risk management, and issues management


US FDA Oversight
  • Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs
  • Drive high-quality communications with FDA that clearly articulate Lilly's scientific position
  • Build and leverage productive relationships with FDA to support product registration goals


Cross-Functional Team Leadership
  • Provide strategic direction to a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global Labeling
  • Foster a culture of transparent communication, feedback, and continuous development
  • Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.
  • Represent GRA at stakeholder and governance meetings; mentor GRA personnel


External Engagement
  • Shape the external regulatory environment by building strategic relationships with key external stakeholders
  • Partner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materials


Minimum Qualifications
  • Advanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug development

OR
  • Bachelor's or Masters and 10+ years of experience in regulatory affairs and/or drug development


Additional Preferences
  • Deep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development process
  • Demonstrated experience with regulatory submissions and agency interactions across US, EU, China, and Japan
  • Direct experience in both clinical and CMC regulatory sciences
  • Strong leadership, negotiation, and stakeholder communication skills - including executive-level audiences
  • Proven ability to assess and manage risk in a highly regulated environment
  • Experience in the applicable therapeutic area


Additional Information
  • Travel expected: 10-15%

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$169,500 - $248,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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