Regulatory Affairs Executive

AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare: cardiovascular, diabetes, respiratory and cancer.

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We believe in the potential of our people and you’ll develop beyond what you thought possible.  We make the most of your skills and passion by actively supporting you to achieve our shared goals no matter where you start with us.

Main Responsibilities

• Develop and implement regulatory strategies to achieve rapid and high quality approvals and facilitate rapid launch for new products and growth platforms, to achieve the company’s business objectives.
• Maintenance of product licenses to a high standard throughout current year, with zero negative impact to business objectives and financial targets.
• Monitor and interpret the local and global regulatory environment for significant changes and communicate implications of such changes to key stakeholders.
• Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs.
• Proactive cross-functional teamwork contributing to optimum business strategies.
• Effective management of the local and global regulatory support systems/information to ensure good coordination for all stakeholders.
• Ensure adherence to AZ and Industry Code of Conduct and Ethics while performing regulatory activities.
• Provide guidance and functional support to regulatory team members to build an effective Regulatory Team.
• Ensure regulatory activities are performed in compliance with AZ Good Regulatory Practice.

Typical Accountabilities

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Regulatory Affairs.
• Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
• report potential issues of non-compliance.

Education, Qualifications, Skills and Experience

• Pharmacy or Scientific Degree or equivalent professional qualification in related field.
• Post-graduate qualification.
• Experience in quality assurance within a pharmaceutical manufacturing environment.
• Minimum 1-2 years of experience in Malaysia market regulatory submissions.
• Familiar with local regulatory requirements and local Health Authority personnel.