Regulatory Affairs Associate

Scorpion Therapeutics; Barrington (IL); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Eton is seeking a Regulatory Affairs Support Specialist to assist labeling, submissions, and compliance for its pharmaceutical products. You will collaborate with Marketing, Medical Affairs, QA, R&D, and Legal to ensure regulatory adherence and maintain organized documentation.

The role requires a Bachelor’s degree in Life Sciences or Chemistry and 2–4 years of regulatory affairs experience, with emphasis on labeling and FDA submissions. Hybrid onsite work in Deer Park, IL is available.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field.
• 2-4 years of regulatory affairs experience in pharma/biotech.
• Experience with regulatory labeling and FDA submissions.

Responsibilities

• Assist with regulatory labeling updates and prepare FDA submissions.
• Maintain regulatory documentation and contribute to lifecycle management.
• Collaborate with Marketing, Medical Affairs, QA, R&D, and Legal to ensure regulatory adherence.
• Track submission deadlines and maintain organized records.

Skills

Regulatory affairs

FDA submissions

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Chemistry

Tools

FDA Form 2253

Job description

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.