Position: Sr. Manager, Regulatory Affairs We invite a proactive and capable Sr. Manager, Regulatory Affairs to lead and execute within a collaborative, agile environment. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Duties and Accountabilities: Support collection and review of adverse event safety data from clinical and post-market sources. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Participate in regulatory inspections, health authority meetings, and internal audits. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Ensure all cases are coded and processed per MedDRA and applicable global standards. Key Skills and Qualifications: 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Effective presentation skills with the ability to communicate complex ideas with clarity. Sound understanding of organisational dynamics and stakeholder management in complex environments. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Critical and strategic thinking skills with the ability to translate insights into clear actions. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Successful candidates will receive access to ongoing professional development and industry-leading resources.