RegulatoryAffairsandPatientSafety

## Accountabilities Support regulatory affairs activities including labeling operations, labeling strategy, advertising and promotion compliance, and chemistry, manufacturing, and controls (CMC) documentation. Assist in preparing, reviewing, and managing regulatory submissions and documentation to ensure compliance with global health authority requirements. Contribute to regulatory operations and publishing activities, ensuring accurate, timely, and compliant submission of dossiers. Support interactions with regional and global health authorities, ensuring alignment with regulatory expectations and guidelines. Participate in patient safety activities including the review, documentation, tracking, and analysis of safety events and signals. Identify trends and risks in patient safety data and contribute to continuous process improvement initiatives. Collaborate with cross-functional teams including clinical, regulatory, and pharmacovigilance stakeholders to ensure integrated delivery. Ensure adherence to applicable regulatory standards, internal procedures, and global compliance frameworks. Support the maintenance of high-quality documentation and contribute to inspection readiness activities. Requirements: Experience in regulatory affairs, pharmacovigilance, or patient safety within the pharmaceutical, biotechnology, or clinical research industry. Strong understanding of regulatory processes, clinical development lifecycle, or drug safety monitoring frameworks. Familiarity with global health authority requirements and regulatory compliance standards. Experience preparing, reviewing, or supporting regulatory submissions or safety reports. Strong analytical skills with attention to detail and ability to interpret complex scientific and regulatory data. Excellent written and verbal communication skills for cross-functional and external stakeholder interaction. Ability to work independently while collaborating effectively in global, matrixed teams. Strong organizational