Regulatory Affairs Specialist

Hybrid Schedule Compensation: Up to $37/hr Position Summary: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support regulatory strategy and compliance activities for our pharmaceutical manufacturing operations in St. Louis, MO. This individual will play a key role in preparing, reviewing, and maintaining regulatory submissions and ensuring compliance with FDA and other global regulatory requirements. The ideal candidate will have experience within a GMP-regulated pharmaceutical environment and a strong understanding of regulatory frameworks governing drug development and manufacturing. Key Responsibilities: Prepare, compile, review, and submit regulatory documents including INDs, NDAs, ANDAs, amendments, supplements, annual reports, and other global submissions as required Support regulatory strategy development for new product registrations and lifecycle management activities Maintain regulatory files and ensure compliance with FDA, ICH, and other applicable regulatory guidelines Serve as a liaison between internal departments (Quality, Manufacturing, R&D, Supply Chain) to ensure alignment on regulatory requirements Assess impact of manufacturing changes, labeling updates, and product modifications on regulatory filings Monitor regulatory intelligence and communicate changes in regulations that may affect the organization Support preparation for FDA inspections and regulatory audits Track submission timelines and ensure adherence to regulatory commitments Qualifications: Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Regulatory Affairs, or related field 2-5+ years of regulatory affairs experience within pharmaceutical or biotech manufacturing Working knowledge of FDA regulations (21 CFR), cGMP requirements, and ICH guidelines Experience with eCTD submissions preferred Strong organizational skills and attention to detail Excellent written and verbal communication skills Ability to manage multiple projects in a fast-paced environment Preferred Qualifications: Experience supporting CMC documentation and post-approval lifecycle management Familiarity with global regulatory submissions (EU, Canada, etc.) RAC certification (a plus)

Created: 2026-03-04