Role
Support regulatory activities for Eton's pharmaceutical products, focusing on labeling, submissions, and compliance.
Responsibilities
assist with regulatory labeling updates, prepare and submit FDA forms (including Form FDA 2253 for promotional materials), maintain regulatory documentation, and support lifecycle management for marketed products. Collaborate closely with cross-functional teams such as Marketing, Medical Affairs, QA, R&D, and Legal to ensure regulatory adherence. Maintain organized records, track submission deadlines, and contribute to process improvements.
Requirements
Bachelor's degree in Life Sciences, Chemistry, or related field; 2-4 years of regulatory affairs experience in pharma/biotech, with specific experience in regulatory labeling and FDA submissions.
Preferred
regulatory coursework or certifications like RAC, familiarity with electronic submissions, and experience supporting promotional material review.
HighValue
support for commercial and development-stage products, regulatory labeling and promotional material compliance, FDA Form 2253 submissions, lifecycle management, cross-functional collaboration, hybrid onsite work in Deer Park, IL.
#J-18808-LjbffrRegulatory Affairs Associate in barrington at Unknown Company
This position is listed as full time and hybrid.