CMC Regulatory Affairs Project Manager (Hybrid)

The Fountain Group; Illinois; Hybrid; USD 45,000 - 48,000; Full time

Job summary

The Fountain Group seeks a Regulatory Affairs CMC Project Manager on a hybrid Lake County, IL site with a 6-month initial contract. The role focuses on authoring, coordinating, and managing CMC submissions and CTD Module 3 content to ensure timely filings.

Ideal candidates have 4+ years in pharma, strong cross-functional coordination, and experience with US and international regulatory dossier requirements. Hybrid work and contract duration are noted in the posting.

Qualifications

• 4+ years in pharmaceutical industry
• Experience authoring, compiling, or managing CMC regulatory submission documents
• Knowledge of CTD structure, particularly Module 3 requirements
• Experience coordinating cross-functional regulatory projects and submission timelines
• Familiarity with U.S. and international regulatory dossier requirements
• Experience using electronic document management systems
• Ability to manage multiple regulatory projects independently

Responsibilities

• Manage authoring, compilation, and coordination of CMC sections for submissions
• Develop CTD Module 3 content and project timelines with cross-functional teams
• Ensure regulatory dossiers meet accuracy, completeness, formatting and submission requirements
• Lead document review meetings and track project milestones
• Coordinate regulatory documentation activities to support timely filings and acceptance

Skills

CMC knowledge

Regulatory submissions

Cross-functional coordination

CTD Module 3

Document management

Independent work

US & intl regs

Education

Bachelor’s degree in Chemistry/Biology or related field

Tools

Electronic Document Management System

Job description

The Fountain Group seeks a Regulatory Affairs CMC Project Manager on a hybrid Lake County, IL site with a 6-month initial contract. The role focuses on authoring, coordinating, and managing CMC submissions and CTD Module 3 content to ensure timely filings.

Ideal candidates have 4+ years in pharma, strong cross-functional coordination, and experience with US and international regulatory dossier requirements. Hybrid work and contract duration are noted in the posting.