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Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Small Molecules

May 9, 2026

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio and to support clinical trial applications, market registrations, and post approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.Key Responsibilities<ul><li>Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).</li><li>Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.</li><li>Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).</li><li>Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.</li><li>Leads preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests.</li><li>Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.</li><li>Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.</li><li>Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.</li></ul>Basic Qualifications/Requirements<ul><li>B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.</li><li>10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than ten years of experience are encouraged to apply.</li></ul>Additional Skills/Preferences<ul><li>Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.</li><li>Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives.</li><li>Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.</li><li>Demonstrated deep knowledge of the synthetic molecule drug development process.</li><li>Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.</li><li>Experience planning for and participating in Health Authority meetings.</li><li>Demonstrated ability to assess and manage risk in a highly regulated environment.</li><li>Demonstrated strong written, spoken and presentation communication skills.</li><li>Demonstrated leadership behaviors and negotiation and influence skills.</li><li>Demonstrated attention to detail.</li><li>Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.</li></ul>Additional Information<ul><li>Position Location: Indianapolis, IN. A remote option may be considered. Relocation assistance is provided.</li><li>Travel: minimal within the US</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 (<a href="https://careers.lilly.com/us/en/workplace-accommodation" target="_blank" rel="noopener noreferrer">https://careers.lilly.com/us/en/workplace-accommodation</a>) 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is$148,500 - $257,400<h3></h3>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?...

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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...

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