Collabera · 1 day ago
Regulatory Affair Associate
North Chicago, IL
Contract
Hybrid
Entry Level
$40/hr - $45/hr
1+ years expCollabera is a company in the pharmaceutical industry, seeking a Regulatory Affair Associate. This role is responsible for managing and compiling Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions and partnering with cross-functional teams to ensure compliance with regulatory requirements.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Deepak Arya
Responsibilities
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
Qualification
Required
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
Preferred
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
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
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2024-04-09
2023-01-20
2022-04-19
Company data provided by crunchbase