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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$61,500 - $143,000

Organization Overview:
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.

Responsibilities:
The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within IMP manufacturing operations. This position supports Lilly/Avid diagnostic radiopharmaceutical products globally.

Support CMC change management, including change control issuing and assessments, as well as task management to ensure compliance with quality management systemsCMC regulatory operations (e.g., coordinate regulatory submission timelines, manage regulatory documents, prepare content plans for regulatory submissions, and maintain submission information according to the Regulatory Information Management (RIM) system)Manage the preparation, review, and submission of global CMC regulatory dossiers and information request responses according to CMC regulatory strategiesAuthor, revise, and/or review technical documentation including but not limited to testing protocols, technical reports, and standard operating proceduresParticipate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plansSupport the establishment and maintenance of infrastructure tools, procedures, and systems for CMC regulatory and CMC developmentKeep current with global regulatory guidelines applicable to CMCPerform other duties as assigned

Basic Requirements:

Bachelor’s degree in a scientific disciplineMinimum of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory, project management, and/or related field

Additional Skills/Preferences:

Organized and detail-orientedStrong communication skills with ability to work within global multi-disciplinary teamsExcellent technical writing skillsAbility to plan, prioritize, and handle multiple tasks concurrentlyAbility to independently complete assigned workload with minimum supervisionAbility to adapt to change and work in a fast-paced environmentStrong MS Office skills

Additional Information:

Must be willing and able to travel within the USA and worldwide 10% of time

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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