Regulatory Affairs Associate II

The Fountain Group; Illinois; Hybride; USD 45 000 - 48 000; Plein temps

Résumé du poste

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

Responsabilités

• 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

Connaissances

CMC knowledge

Regulatory submissions

Cross-functional coordination

CTD Module 3

Document management

Independent work

US & intl regs

Formation

Bachelor’s degree in Chemistry/Biology or related field

Outils

Electronic Document Management System

Description du poste

Job Title: Regulatory Affairs CMC Project Manager
Location: Lake County, IL (Hybrid)
Pay Rate: $33–$35/hour
Duration: 6 Months (Initial Contract)

Job Description

Manage the authoring, compilation, and coordination of Chemistry, Manufacturing, and Controls (CMC) sections for marketed product variation submissions. Develop CTD Module 3 content and project timelines in collaboration with Regulatory Affairs CMC leads and cross-functional teams. Ensure regulatory dossiers and responses meet accuracy, completeness, formatting, and submission requirements. Lead document review meetings, track project milestones, and coordinate regulatory documentation activities to support timely filings and acceptance.

Education

• Bachelor’s degree in Chemistry, Biological Sciences, or a related scientific discipline.

Required Skills

• At least 4 years of pharmaceutical industry experience.

• 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.

Preferred Skills

• At least 5 years of pharmaceutical industry experience, including 1–2 years in Regulatory Affairs, R&D, or Manufacturing.

• Experience preparing CMC sections for marketed product variations.

• Knowledge of regulatory submission best practices and electronic regulatory business systems.

• Experience reviewing technical documentation and coordinating responses to regulatory questions.