Regulatory Affairs Specialist Jobs in Illinois
Regulatory affairs specialist jobs in Illinois are among the most active in the Midwest, concentrated in pharmaceuticals, medical devices, food and beverage, and agrochemicals across a wide seniority range from entry-level associate to senior director. Chicago, the North Shore suburbs, and Peoria are the primary hiring hubs, anchored by longtime employers like Abbott Laboratories, Baxter International, and Archer Daniels Midland. The most in-demand specializations are FDA submissions, quality management systems, and drug and device labeling compliance. Scan the live roles below and apply to whichever ones fit.
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Job Overview
We are seeking a dynamic and detail-oriented CMC Regulatory Affairs Associate to join our team in North Chicago, IL. This role offers an exciting opportunity to contribute to the development and regulatory compliance of innovative biotechnology and pharmaceutical products. As a key member of the regulatory affairs team, you will ensure that our clinical development programs meet all necessary health regulation policies and FDA regulations, supporting the successful progression of clinical trials and regulatory submissions. Your expertise will drive cross-functional collaboration with research, medical affairs, and quality assurance teams to uphold biomedical regulatory compliance and facilitate seamless project management. This position is ideal for a motivated professional eager to make an impact in the biotech industry with a focus on clinical research methods, data analysis, and healthcare compliance.
Duties
- Prepare, review, and submit regulatory documentation for clinical trials, ensuring compliance with FDA regulations, ICH GCP standards, and pharmaceutical regulatory requirements
- Coordinate data collection, data interpretation, and analysis to support regulatory submissions and clinical development activities
- Maintain up-to-date knowledge of health regulation policies, JCAHO standards, and hospital experience requirements relevant to clinical research environments
- Collaborate with cross-functional teams including medical affairs, research scientists, and project managers to streamline clinical research processes and ensure accurate technical writing for researchers
- Manage regulatory dossiers related to biomedical regulatory compliance and oversee documentation for clinical trials conducted at Level I and Level II trauma centers
- Assist in the development of technical writing for medical reports, research papers, and regulatory submissions while adhering to medical terminology standards
- Support health regulation policy updates by conducting research on evolving FDA regulations and healthcare compliance guidelines
Skills
- Strong understanding of clinical research methods, clinical trials processes, and pharmaceutical company experience
- Proven data analysis skills with the ability to interpret complex datasets relevant to clinical development projects
- Excellent technical writing skills tailored for researchers, medical professionals, and regulatory bodies
- Knowledge of FDA regulations, JCAHO standards, healthcare compliance policies, and biomedical regulatory frameworks
- Experience in managing cross-functional collaboration within biotech or pharmaceutical environments
- Familiarity with managed care systems and health regulation policies impacting clinical research operations
- Demonstrated project management abilities with a focus on clinical research timelines and deliverables
- Valid ICH GCP (International Conference on Harmonisation Good Clinical Practice) certificate from a recognized issuer; CA (California) GCP certification preferred
- Strong communication skills with the ability to convey complex scientific information clearly and effectively
Join us in advancing healthcare innovation by ensuring our products meet the highest standards of safety, efficacy, and regulatory compliance. Your expertise will help shape the future of biomedical breakthroughs while supporting a collaborative environment dedicated to excellence in clinical research.
Pay: $27.00 - $30.00 per hour
Work Location: In person
See All 26 Regulatory Affairs Specialist Jobs in Illinois
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Find JobsRegulatory Affairs Specialist Jobs by City in Illinois
Where Illinois roles are concentrated, by current openings.
Regulatory Affairs Specialist Job Market in Illinois
A snapshot from current Illinois openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Education
- Healthcare & Medical Services
- Biotechnology & Pharmaceuticals
- Consulting & Professional Services
What Illinois Employers Look For
The qualifications that appear most often in regulatory affairs specialist jobs across Illinois.
- Bachelor's degree in life sciences, chemistry, engineering, or a related technical field required
- Experience with FDA regulatory submissions including 510(k), PMA, or NDA filings strongly preferred
- Familiarity with CFR Title 21, ISO 13485, and ICH guidelines for applicable product categories
- Proficiency with regulatory information management systems such as Veeva Vault or similar platforms
- Strong technical writing skills for preparing dossiers, SOPs, and regulatory correspondence
- RAC credential from the Regulatory Affairs Professionals Society viewed favorably by Illinois employers
Regulatory Affairs Specialist Jobs in Illinois: Frequently Asked Questions
How do you become a regulatory affairs specialist in Illinois?
Start with a bachelor's degree in a life science, pharmacy, chemistry, or engineering discipline, which is the baseline Illinois employers expect. Illinois does not issue a state license specific to regulatory affairs, so the path to employment runs through relevant industry experience and credentials. The Regulatory Affairs Professionals Society offers the RAC certification, which Illinois pharmaceutical and medical device employers treat as a strong differentiator. Entry candidates typically build experience through quality assurance, clinical operations, or laboratory roles before moving into regulatory work.
How much do regulatory affairs specialists make in Illinois?
Regulatory affairs specialists in Illinois earn a median of about $80,550 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $50,040 for the lowest 10% to over $132,290 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs specialists in Illinois?
Illinois regulatory affairs specialist roles are posted by AbbVie, Covista, and Medline Industries and others right now, based on current listings on Migrate Mate as of September 2026. Illinois's dense concentration of pharmaceutical, medical device, and food ingredient manufacturers along the I-294 corridor and in the greater Chicago metro makes it one of the most consistent states for regulatory affairs hiring nationwide.
Which Illinois cities have the most regulatory affairs specialist jobs?
Chicago, North Chicago, and Niles lead Illinois for regulatory affairs specialist openings. Chicago drives volume through its large pharmaceutical and biotech company presence and corporate headquarters, while the North Shore suburbs like Lake County and Deerfield reflect the campuses of major device and drug manufacturers, and Peoria draws openings from agricultural chemical and food processing operations anchored in central Illinois.
Are there remote regulatory affairs specialist jobs in Illinois?
Yes, and more than most fields. Regulatory affairs work is largely desk-based, involving document preparation, agency correspondence, and database submissions that translate well to remote arrangements. About 76% of regulatory affairs specialist openings tied to Illinois are remote or hybrid as of September 2026, making it one of the more flexible roles in the life sciences sector. Submission-focused and labeling roles tend to be the most remote-eligible, while positions requiring lab or manufacturing interaction are more likely to require on-site presence.
How can I get hired as a regulatory affairs specialist in Illinois with little or no experience?
The most realistic entry path is moving laterally from a quality assurance, clinical research associate, or laboratory technician role, where you already work with regulated processes and documentation. Illinois pharmaceutical and device employers including Abbott, Baxter, and Horizon Therapeutics run associate regulatory affairs programs and rotational development tracks that accept candidates with limited direct regulatory experience. Pursuing the RAC-Associate designation through the Regulatory Affairs Professionals Society and building a portfolio of SOPs or submission summaries through coursework or volunteer work substantially strengthens an Illinois application at the entry level.
Where can I find and apply to regulatory affairs specialist jobs in Illinois?
You can find and apply to regulatory affairs specialist jobs in Illinois on Migrate Mate, which lists current Illinois openings updated regularly. Search the available roles, identify the ones that match your background and target industry, and apply directly to whichever positions fit.
See All 26 Regulatory Affairs Specialist Jobs in Illinois
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