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Lilly Associate Director CMC Regulatory in Philadelphia, Pennsylvania

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare. For more information, visit www.avidrp.com .

Position Overview:

The Associate Director, CMC Regulatory is responsible for leading CMC regulatory for multiple countries, which includes all relevant CMC regulatory submissions and supporting global CMC regulatory operations. In addition, this position is responsible for reviewing change controls to assess country-specific CMC regulatory impact.

Responsibilities:

  • Lead CMC regulatory for multiple countries/regions

  • Lead CMC regulatory submissions including overall submission project, cross-functional communication, timelines, drafting (self- and cross-functional), editing, formatting, reviewing, and publishing

  • 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 Avid RP’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

  • Other duties as assigned

Basic Qualifications:

  • Bachelor’s degree in Chemistry or related field

  • Minimum of 5 years of CMC regulatory experience

Additional Skills/Preferences:

  • 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

  • Impeccable organizational skills

  • Superior written and verbal communication skills

  • Excellent computer skills (e.g. Excel, Project, Access)

  • Understanding of GMPs and regulatory requirements

Additional Information:

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

  • Lilly currently anticipates that the base salary for this position could range from between $103,500 to $152,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

Eli 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 ( LillyRecruitingCompliance@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.

As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.

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!

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