Associate Director - CMC Regulatory

Eli Lilly and Company-posted 3 days ago

Full-time • Mid Level

Philadelphia, PA

5,001-10,000 employees

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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.

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

B.S. degree in a science, engineering, or a related field (advanced degree preferred)
Experience in pharmaceutical development and/or manufacturing including a minimum of five years of regulatory CMC experience or related.

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

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).

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Associate Director - CMC Regulatory

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