Senior 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 & growth platforms, to achieve the company’s business objectives.
• Maintenance of existing Product Licences, with zero negative impact to business objectives & financial targets.
• Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders.
• Effective management of the local and global regulatory support systems/information to ensure good coordination for all stakeholders
• Proactive cross-functional teamwork contributing to optimum business strategies.
• Aid in building an effective Regulatory Team
• Adherence to AZ and Industry Code of Conduct, ethics, PhAMA Code and Good Regulatory Practices (GRP) and ensure high standard of Regulatory Practices
• Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs.
• Ensure regulatory activities are perform 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

Essential Requirements

• Degree or equivalent professional qualification in bioscience related field
• Min. 2-3 years’ experience in Malaysia market regulatory submission
• Familiar with quality assurance requirement within a pharmaceutical manufacturing environment

Desirable Requirements

• Experience in pharmaceutical QMS requirement

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.