Instagram
youtube
Facebook

Associate / Manager – Cmc Regulatory And Imp Manufacturing Operations

1+ years
$61,500 – $143,000
10 June 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.