Associate Director - CMC Regulatory

Lilly • Philadelphia, PA

12d • $132,000 - $193,600

About The Position

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 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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees