Sr. Regulatory Affairs Specialist

Role: Senior Regulatory Affairs Specialist responsible for preparing and submitting regulatory filings domestically and internationally. Objectives: ensure timely, compliant submissions that meet regulatory standards. Responsibilities: prepare regulatory documents, manage filing processes, maintain compliance with applicable regulations and internal SOPs. Requirements: relevant degree in life sciences, experience in regulatory affairs; familiarity with domestic and international submission processes. Preferred: prior experience with regulatory filings in biopharma, knowledge of global regulations and submission platforms. High-Value: focus on regulatory submissions in biopharma; compliance with FDA, EMA, or other authorities; handling domestic and foreign dossiers; adherence to GxP and SOPs. Collaboration: work closely with cross-functional teams including R&D, quality, and manufacturing to ensure regulatory readiness. Work Setup: not specified; assumed office or hybrid environment.