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
