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Associate Director - Global Regulatory Affairs - Product Communications

June 26, 2026

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Organization Overview The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership and influence to deliver accurate, balanced, and substantiated product and disease communications for assigned assets. The Associate Director partners with Regulatory Scientists, across Lilly brand teams, partner companies, and FDA Office of Prescription Drug Promotion (OPDP) to advise on regulatory requirements and expectations for compliant communications. Responsibilities Within the role, the Associate Director will have the responsibility to provide regulatory guidance in the following areas: Review of Promotional Tactics and Communication <ul><li>Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affairs communications, and campaign tactics for media events</li><li>Provide high quality, prompt and conclusive regulatory advice that enables business partners to make well-informed decisions</li><li>Communicate regulator expectations by utilizing OPDP feedback received by Lilly, interpretation of applicable laws, regulations and guidances, and knowledge of FDA enforcement actions.</li><li>Contribute to business risk mitigation strategies by following trends in external environment related to advertising, promotion and medical communication topics</li><li>Build, maintain, and utilize relationships with Lilly team members and partner companies, as appropriate, to effectively influence the implementation of appropriate communications.</li><li>Initiate promotional tactic discontinuation plans for Regulatory-initiated events </li></ul>Facilitate Interaction with FDA OPDP <ul><li>Counsel internal partners on OPDP advisory strategy; collaborate with marketing and advertising agency in development of promotional proposals, and provide quality review of submission documents</li><li>Partner with US brand team to interpret OPDP advice and support any interactions with OPDP</li><li>Provide a well-timed and quality review of 2253 promotional material submissions to FDA </li></ul>Collaborate With Other Regulatory Colleagues <ul><li>Engage US Regulatory Scientist in 1) development and analysis of promotional claims and suggest marketing on promotional strategy and 2) review of press materials and IR communications.</li><li>Work closely with US Regulatory Scientist and Labeling Operations to lead labeling revisions to balance consideration of business implication and regulatory compliance</li><li>Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity </li></ul>Lead/Influence/Partner <ul><li>Engage in forums that share regulatory information across the organization, other Lilly teams, and business partners</li><li>Constructively challenge teams to reach the best solutions to issues</li><li>Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions </li></ul>Minimum Qualifications Requirements <ul><li>Bachelor's Degree</li><li>3+ years of industry-related experience in drug development and/or commercialization</li><li>Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1 </li></ul>Additional Skills/Preferences <ul><li>Knowledge of FDA procedures and practices (CFR guidelines, Guidances, etc.)</li><li>Demonstrated ability to influence without authority and ability to deliver complex projects against a timeline.</li><li>Strong communication skills (active listening, verbal, and written)</li><li>Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities</li><li>Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles</li><li>Recent experience reviewing advertising and promotional materials for prescription drug products.</li><li>Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.) </li></ul>Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $132,000 - $193,600 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

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...