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ASAstrazeneca logo

Astrazeneca

Malaysia - Petaling Jaya, Malaysia

Senior Regulatory Affairs Executive.

SENIOR LEVEL
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. Date Posted 02-Nov-2026 Closing Date 01-Dis-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
Pay
Not stated
Where
Malaysia - Petaling Jaya, Malaysia
Work
Not stated
Type
Not stated
Posted
2 Nov, 2026
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