Collabera · 4 days ago
Regulatory Affairs Associate
North Chicago, IL
Contract
Onsite
Entry Level
$30/hr - $36/hr
1+ years expCollabera is seeking a Regulatory Affairs Associate I to support regulatory submission activities for marketed pharmaceutical products. This role involves managing documentation related to chemistry, manufacturing, and control while ensuring compliance and timely submissions in collaboration with cross-functional teams.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Gagandeep Singh
Responsibilities
Manage, compile, and author chemistry, manufacturing, and control sections for marketed product variations
Ensure submission documents meet required content, structure, and formatting standards
Coordinate activities across regulatory, research and development, manufacturing, and quality teams
Facilitate project team meetings and drive timelines with minimal supervision
Manage multiple regulatory projects to ensure accuracy, completeness, and on-time delivery
Monitor changes in project scope or priorities and adjust plans accordingly
Maintain awareness of current regulatory requirements and best practices for regulatory systems
Support preparation of responses to regulatory agency questions and requests
Qualification
Required
Bachelor's degree in chemical sciences, biological sciences, or a related discipline
One to two years of experience in the pharmaceutical industry
One to two years of cross-functional project management experience
Familiarity with chemistry, manufacturing, and control documentation and CTD structure
Experience with electronic document management systems
Strong written and verbal communication skills
Ability to work independently and collaboratively in a team environment
Strong attention to detail and organizational skills
Preferred
One to two years of experience in regulatory affairs, research and development, or manufacturing
Familiarity with United States and international regulatory requirements
Experience supporting CTD Module Three content development
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 off
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
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