Regulatory Affairs Manager

Company Overview ASTRAZENECA SINGAPORE PTE LTD is a global biopharmaceutical company focused on developing innovative medicines to improve patient health and meet regulatory standards worldwide. Job Summary Develop and implement regulatory strategies to secure rapid, high-quality approvals and ensure compliance with local and global regulations. Lead quality assurance processes and promote good regulatory practices to support business objectives and maintain operational licenses. Responsibilities Develop regulatory strategies that achieve timely approvals and ensure compliance with regulatory requirements to support business goals Implement quality assurance processes aligned with local and global standards to maintain company licenses and regulatory compliance Coordinate and influence cross-functional teams including commercial, medical, and market access to drive regulatory submissions and approvals Build and maintain strong relationships with internal and external stakeholders to facilitate regulatory processes Apply project management skills to plan, organize, and execute regulatory activities effectively Work independently with self-motivation to meet deadlines and manage multiple priorities under pressure Communicate regulatory requirements and updates clearly to relevant teams to ensure alignment and compliance Required competencies and certifications Bachelor’s degree in Pharmacy or related field Minimum 5 years’ experience in regulatory affairs for product registration Preferred competencies and qualifications Registered pharmacist Master’s degree Experience in vaccines and/or medical devices regulatory affairs Knowledge of regulatory operations, GxP compliance, and regulatory policy Experience in a similar regulatory role within a multinational pharmaceutical company