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.

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 35,000 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.

Position Overview:

The Director, CMC Regulatory will leverage CMC technical knowledge and regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products.  This includes the delivery of all relevant CMC regulatory submissions globally.

Responsibilities:

Responsible for the generation and execution of country specific CMC regulatory strategies for investigational and commercial radiopharmaceutical products.  

Lead global CMC regulatory submissions including authoring, review, and finalization

Lead and contribute to responses to regulatory agency questions globally

Review change controls to assess country-specific CMC regulatory impact

Review technical documents including testing protocols, technical reports, and CMO procedures and specifications from a CMC regulatory perspective

Demonstrate an in-depth understanding of CMC regulatory requirements across multiple regions

Monitor and evaluate new regulations / guidance, regulatory changes / trends pertaining to CMC regulatory and communicate with internal stakeholders

Managing small group of CMC regulatory professionals

Perform other duties as assigned

Basic Qualifications:

BS Degree in science, engineering, or a related field

Minimum of 10 years in pharmaceutical drug development and/or pharmaceutical manufacturing with a minimum of five years of direct CMC regulatory experience.

Additional Skills/Preferences:

Advanced degree strongly preferred

PET drug experience preferred

Ability to manage people and drive engagement among teams

Demonstrated strong written, spoken and presentation communication skills.

Excellent technical writing skills

Ability to plan and align

Ability to adapt to change and be a nimble learner

Ability to ensure accountability of oneself and others

Demonstrated leadership behaviors and negotiation and influence skills

Creative thinking and ability to cultivate innovation

Demonstrated attention to detail

Excellent MS Office skills

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 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

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.

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