Job Title:
Associate / Manager – CMC Regulatory and IMP Manufacturing Operations
Location:
Philadelphia, Pennsylvania, United States
Job ID: R-78482
Category: Research & Development
Job Type: Full-Time, Regular
Company Overview:
Eli Lilly and Company is a global leader in healthcare innovation, focused on delivering medicines that improve lives. Headquartered in Indianapolis, Lilly combines care and science to discover, develop, and manufacture therapies that make a real difference.
Position Summary:
This hybrid role supports CMC Regulatory Operations and Investigational Medicinal Product (IMP) Manufacturing within the CMC Development team, focusing on radiopharmaceutical products. The Associate/Manager ensures regulatory compliance, manages change controls, and coordinates global CMC submissions to support product development and lifecycle management.
Key Responsibilities:
Manage CMC regulatory submissions and documentation lifecycle.
Coordinate global submission timelines and content plans per regulatory information systems.
Author and review technical documentation (e.g., SOPs, reports, testing protocols).
Ensure compliance with change management systems.
Support cross-functional team efforts, infrastructure tools, and regulatory strategy alignment.
Stay up to date on global CMC regulatory guidelines.
Basic Qualifications:
Bachelor’s degree in a scientific discipline.
Minimum of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory, or project management.
Preferred Skills:
Strong attention to detail and excellent organization.
Effective communication and technical writing skills.
Ability to prioritize tasks, work independently, and handle a dynamic workload.
Proficiency with Microsoft Office.
Comfortable working in a fast-paced, global environment.
Additional Info:
Travel Requirement: Up to 10% (domestic and international)
Location: Philadelphia, PA (not remote)
Compensation Range:
$61,500 – $143,000
Includes eligibility for performance-based bonuses and a full suite of benefits (401(k), pension, healthcare, vacation, wellness perks, etc.).
Inclusivity:
Lilly values diversity and provides equal employment opportunities. Workplace accommodations are available upon request:
👉 Accommodation Request Form
Employee Resource Groups (ERGs):
Inclusive communities like PRIDE, WILL, enAble, VLN, OLA, and others offer support and connection across the company.
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