Associate Director
3 weeks ago
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 Associate Director – CMC Regulatory is responsible for leading global CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC regulatory impact of change controls.
Responsibilities:
Responsible for the generation and execution of country specific CMC regulatory strategiesLead CMC regulatory submissions including overall submission project, cross-functional communication, timelines, drafting (self- and cross-functional), editing, formatting, reviewing, and publishingLead and contribute to responses to regulatory agency questionsDevelop and maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior leadershipReview change controls (globally) to assess country-specific CMC regulatory impactMaintain understanding and working knowledge of regulatory requirements applicable to CMC regulatory in applicable geographiesSupport CMC development projects as needed from CMC regulatory perspectiveDevelop understanding and working knowledge of Lilly/Avid radiopharmaceutical’s manufacturing and analytical procedures and method validationsReview technical documents including testing protocols, technical reports, and CMO procedures and specifications from a CMC regulatory perspectivePerform other duties as assignedBasic Qualifications:
Bachelor’s and/or Master's degree in chemistry or related field, or PharmD.Experience in pharmaceutical development and/or manufacturing with 5+ years of CMC regulatory experience or related experience (e.g. CMC writer).Additional Skills/Preferences:
Excellent technical writing skillsPET drug experience preferredAbility to work independently within a team in a highly focused manner to manage complex situationsAbility to adapt to change and be a nimble learnerAbility to manage people and drive engagement among teamsAbility to ensure accountability of oneself and othersAbility to plan and alignCreative thinking and ability to cultivate innovationOrganized and detailed orientatedStrong MS Office skillsMust be willing and able to travel within the USA and worldwide 10% of timeAdditional Information:
Must be willing and able to travel within the USA and worldwide 10% of timeEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
#WeAreLilly
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