Regulatory Affairs Manager

Job Summary

To support regulatory compliance and strategy, the full-time remote Regulatory Affairs Manager will manage the preparation of CMC post-market supplements and facility registrations while coordinating with cross-functional teams and regulatory agencies.

Key responsibilities

• Define regulatory filing requirements and provide strategic guidance for post-approval programs
• Maintain product compliance through regulatory filings and support change management activities
• Facilitate agency interactions and prepare necessary documentation for regulatory meetings

Required qualifications

• Doctorate degree, or a Master's degree with 2 years of Regulatory Affairs experience, or a Bachelor's degree with 4 years of experience, or an Associate's degree with 8 years of experience, or a high school diploma/GED with 10 years of experience in Regulatory Affairs
• Experience in Regulatory CMC within the pharmaceutical or biotechnology industry
• Working knowledge of ICH guidelines and current GMP and GCP requirements
• Experience preparing regulatory dossiers in accordance with ICH guidelines and CTD structure
• Background in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA)