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Regulatory Assurance Manager

  • Atlanta, GA, USA
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Leonid Group is excited to be retained by a leading pharmaceutical company to hire a Regulatory Assurance Manager based in Atlanta, GA.  

Role Overview 

Reporting to the Senior Director, Regulatory Affairs, the Regulatory Assurance Manager will be responsible for the preparation, coordination, and quality assurance of U.S. regulatory submissions, ensuring full compliance with FDA requirements and internal regulatory standards. This role is central to maintaining inspection readiness and regulatory excellence. 

Key Responsibilities 

  • Lead the preparation, review, and submission of U.S. regulatory filings (e.g., INDs, NDAs, BLAs, supplements, amendments). 

  • Ensure accuracy, completeness, and compliance of regulatory documentation with FDA regulations and guidance. 

  • Coordinate cross-functional inputs from R&D, Quality, Clinical, Manufacturing, and Pharmacovigilance. 

  • Support regulatory inspections, audits, and information requests from U.S. authorities. 

  • Maintain regulatory submission timelines, trackers, and documentation repositories. 

  • Contribute to continuous improvement of regulatory processes and assurance frameworks. 

Key Requirements 

  • 7–10+ years of experience in Regulatory Affairs or Regulatory Assurance within the pharmaceutical industry. 

  • Strong hands-on experience with U.S. FDA submissions and regulatory processes. 

  • In-depth knowledge of U.S. regulatory requirements and lifecycle management. 

  • Excellent project management and cross-functional coordination skills. 

  • Bachelor’s or advanced degree in life sciences or a related field. 

 

Leonid Group Corporate Governance is a talent advisory firm that specialises in the placement of Legal, Compliance, Risk, ESG and Sustainability and Audit professionals on an international scale across the Americas, EMEA, and APAC. These are global disciplines with teams worldwide, and our network reflects this. We work with multinational corporations to help structure their departments with the best people, from the Global Chief Compliance Officer and General Counsel to the Compliance Analyst and Trade Compliance Specialist. 

Apply now