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

100 Eli Lilly and Company; Indianapolis (IN); Hybrid; USD 149,000 - 257,000; Full time

Benefits offered by this job

Remote option may be considered

Relocation assistance

Bonus eligibility

Job summary

Eli Lilly and Company in Indianapolis, IN, is seeking a regulatory CMC leader to drive technical strategy and execution across small molecule development and manufacturing. This role integrates with global teams to accelerate clinical trial applications, registrations, and post-approval activities.

You will provide high-quality regulatory advice, manage complex submissions, and influence product lifecycle decisions while navigating evolving global guidelines.

Qualifications

• 10+ years in regulatory CMC or technical CMC for synthetic molecules.
• Experience supporting clinical development and/or commercialization.
• Proven ability to develop regulatory strategies and regulatory submissions.

Responsibilities

• Provide regulatory CMC leadership across therapeutic modalities and manufacturing technologies.
• Lead preparation and review of CMC documents for global submissions.
• Guide development teams on lifecycle planning and decisions.
• Lead health authority communications and responses.
• Assess regulatory risk and provide clear regulatory advice to project teams.
• Collaborate with cross-functional teams to align regulatory strategies.

Skills

Regulatory CMC leadership

Global regulatory knowledge

Strategic regulatory planning

Communication skills

Cross-functional collaboration

Education

B.S. in science/engineering or STEM field

Advanced degree preferred

Job description

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

• Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
• Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).
• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
• 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.
• Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
• Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.
• Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

Basic Qualifications/Requirements

• 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.
• 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.

Additional Skills/Preferences

• Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.
• Knowledge of major market procedures, regulations, and practices.
• Awareness of evolving regulatory initiatives.
• Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
• Demonstrated deep knowledge of the synthetic molecule drug development process.
• Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
• Experience planning for and participating in Health Authority meetings.
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Additional Information

Position Location: Indianapolis, IN. A remote option may be considered. Relocation assistance is provided. Travel: minimal within the US

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 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.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!