Senior Executive - Regulatory Affairs | Post Approval

Role Overview: You should have a good knowledge of ANDA submission activities and post-approval procedures along with related ICH and USFDA guidelines. Your responsibilities will include API DMF review in accordance with USFDA regulatory requirements, exposure to various dosage forms, preliminary review of change cases, drafting annual reports, reviewing submission packages, drafting controlled correspondence, and ensuring regulatory submissions are completed without delay. Coordination with cross-functional teams and maintaining regulatory information will also be part of your role. Key Responsibilities: - Review API DMF with respect to USFDA regulatory requirements - Understand and brief manufacturing processes of various dosage forms - Preliminarily review change cases based on ICH quality and post-approval USFDA guidance - Draft annual reports in compliance with USFDA guidance - Review entire submission packages - Draft controlled correspondence and briefing packages for FDA - Coordinate with cross-functional teams for document availability - Ensure timely drafting and compiling of regulatory submissions - Maintain regulatory information as per assigned tasks - Demonstrate skills in drafting Regulatory CTD modules Qualifications: - M. Pharm Note: Amneal is an equal opportunity employer and values diversity and inclusion in the workplace.,