Collabera · 1 day ago
Regulatory Affairs Associate
North Chicago, IL
Contract
Hybrid
Entry Level
$34/hr - $38/hr
1+ years expCollabera is a company in the Biotechnology and Pharmaceutical Research industry, and they are seeking a Regulatory Affairs Associate I to support regulatory submission activities for pharmaceutical products. This role involves authoring and managing CMC documentation, ensuring compliance and timely submissions with minimal oversight.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Siddhi Kadakia
Responsibilities
Author, compile, and manage CMC sections (CTD Module 3) for marketed product variations
Ensure regulatory documents meet structural, formatting, and content requirements
Manage assigned regulatory projects to ensure accuracy, completeness, and on-time delivery
Partner with Regulatory Affairs CMC Project Leads to develop submission strategies and timelines
Coordinate cross-functional contributors to support regulatory filings
Facilitate project team and document review meetings independently
Track changes in project scope and adjust priorities as needed
Support regulatory responses and dossier updates as required
Maintain awareness of current regulatory best practices and internal regulatory systems
Ensure submissions are compliant, file-ready, and acceptable to regulatory agencies
Qualification
Required
Bachelor's degree in Chemical Sciences, Biological Sciences, or a closely related scientific discipline
1-2 years of experience in the pharmaceutical industry
1-2 years of cross-functional project management experience
Preferred
Prior experience in Regulatory Affairs, R&D, or Manufacturing with exposure to CTD Module 3 (CMC) content
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 ti
Paid sick and safe tim
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
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