Associate Director - CMC Regulatory

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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.

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 strategies
• Lead CMC regulatory submissions including overall submission project, cross-functional communication, timelines, drafting (self- and cross-functional), editing, formatting, reviewing, and publishing
• Lead and contribute to responses to regulatory agency questions
• Develop and maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior leadership
• Review change controls (globally) to assess country-specific CMC regulatory impact
• Maintain understanding and working knowledge of regulatory requirements applicable to CMC regulatory in applicable geographies
• Support CMC development projects as needed from CMC regulatory perspective
• Develop understanding and working knowledge of Lilly/Avid radiopharmaceutical's manufacturing and analytical procedures and method validations
• Review technical documents including testing protocols, technical reports, and CMO procedures and specifications from a CMC regulatory perspective
• Perform other duties as assigned

Basic Qualifications:

• Bachelor's Degree, or Master's degree, or PharmD.
• Experience in pharmaceutical development and/or manufacturing with 5+ years of CMC regulatory experience or related experience (e.g. CMC writer).
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Additional Skills/Preferences:

• Excellent technical writing skills
• PET drug experience preferred
• Ability to work independently within a team in a highly focused manner to manage complex situations
• Ability to adapt to change and be a nimble learner
• Ability to manage people and drive engagement among teams
• Ability to ensure accountability of oneself and others
• Ability to plan and align
• Creative thinking and ability to cultivate innovation
• Organized and detailed orientated
• Strong MS Office skills
• Must be willing and able to travel within the USA and worldwide 10% of time

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 ( ) 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.

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