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Regulatory Affair Associate
Contract: North Chicago, Illinois, US
Salary Range: 30.00 - 35.00 | Per Hour
Job Code: 366695
End Date: 2026-02-06
Days Left: 12 days, 1 hours left
To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!
Pay Range: $30 to $35 an hour.
Client Industry: Pharmaceutical
Job Mode: Hybrid (Onsite Tuesday – Thursday)
Contract Duration: 07 Months (++Possibilities of Extension)
Mission:
This role is responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Controls (CMC) documentation for marketed product variations and regulatory submissions. The position partners closely with cross-functional teams to ensure CMC sections meet regulatory, structural, and formatting requirements. The goal is to deliver accurate, timely, and submission-ready documentation that supports regulatory filings and ongoing product lifecycle activities. The role operates with a high level of independence and ownership across multiple projects.
Must Haves:
- 1–3 years of experience in pharmaceutical or regulated product environments
- Hands-on experience authoring and compiling CMC documentation
- Working knowledge of CTD structure and Module 3 content
- Experience coordinating cross-functional project teams
- Familiarity with U.S. and international regulatory requirements for dossiers
- Experience using electronic document management systems
- Strong written and verbal communication skills
- Bachelor’s degree in Chemical Sciences, Biological Sciences, or a related discipline.
Day to Day
- Author, compile, and manage CMC sections for marketed product variations
- Ensure CTD content meets regulatory, structural, and formatting requirements
- Manage timelines, accuracy, and completeness of CMC dossiers and responses
- Coordinate activities with regulatory, manufacturing, R&D, and quality teams
- Lead and facilitate document review and submission meetings
- Monitor changes in project scope and adjust priorities as needed
- Apply current best practices for regulatory documentation systems
- Support regulatory filings and submission readiness activities
Plusses
- Experience in Regulatory Affairs, R&D, or Manufacturing environments
- Direct experience with CTD Module 3 authoring
- Exposure to global regulatory submissions
- Experience supporting regulated medical products or devices
- Advanced scientific degree.
Benefits:
Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
Job Requirement
- CMC Documentation
- Module 3
- CTD structure
Reach Out to a Recruiter
- Recruiter
- Phone
- Deepak Arya
- deepak.arya@collabera.com
Apply Now
Apply Now
