Regulatory Associate

Location: Raleigh, NC (Open to Remote) Duration: 5-Month Contract Job Summary The Regulatory Associate will support regulatory personnel in preparing and managing regulatory documentation for development projects. This role involves assisting with regulatory submissions, preparing documentation for regulatory agency interactions, and maintaining product labeling and artwork to ensure compliance with regulatory standards. Key Responsibilities 1. Regulatory Documentation and Submissions Support Assist regulatory personnel with the preparation and completion of work packages for development projects. Draft meeting requests and briefing packages for meetings with the FDA. Assist in the preparation and submission of regulatory documents including: Investigational New Drug (IND) Applications Supplemental Biologic License Applications (sBLA) Supplements to Marketing Applications (Labeling, Efficacy, and CMC) Pediatric Study Plans Orphan Drug Applications Clinical Trial supporting documentation such as: Protocol Amendments Investigator Updates Investigator’s Brochure Harmonization Requests IND Safety Reports 2. Labeling and Artwork Maintenance Assist regulatory personnel with labeling and artwork updates across all products. Review labeling changes and perform quality checks to ensure accuracy and compliance with regulatory requirements. Support documentation and tracking of labeling revisions and approvals. Required Skills and Qualifications Experience or familiarity with regulatory documentation and submission processes. Knowledge of regulatory requirements related to FDA submissions. Strong attention to detail with the ability to perform quality checks on technical documents. Excellent written communication skills for drafting regulatory documentation. Ability to work collaboratively with cross-functional teams. Strong organizational and time-management skills. Work Arrangement Location: Raleigh, NC (remote candidates will be considered). Contract Duration: 5 months.