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