Hybrid Schedule

Compensation: $30-48/hr (depending on experience)

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 client 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