Illinois Regulatory Affairs Associate

A company is looking for a Regulatory Affairs Associate I.

Key Responsibilities

Manage activities for marketed product variations, including authoring and compiling CMC sections for submission documents

Coordinate activities with functional departments to support regulatory filings

Ensure accuracy and timeliness of CMC dossiers and responses while managing assigned projects

Required Qualifications

Experience in regulatory affairs, specifically with CMC sections

Ability to work in a hybrid role, with onsite presence required on specific days

Familiarity with CTD content and structural requirements for regulatory submissions

Experience with PMA supplements is a plus

Willingness to relocate at own expense if not local