Senior Regulatory Affairs Executive

AstraZeneca; Petaling Jaya; Presencial; MYR 120.000 - 180.000; Jornada completa

Descripción de la vacante

AstraZeneca plc in Malaysia is seeking a Regulatory Affairs professional to develop and implement strategies for rapid product approvals and launches, while maintaining existing licences and compliance. The role requires 2–3 years of local submission experience, QA familiarity, and the ability to build strong relationships with health authorities and cross-functional teams.

Join a global leader committed to high regulatory standards and ethical practices, with opportunities to grow within the

Formación

• Degree or equivalent professional qualification in bioscience related field.
• Min. 2-3 years’ experience in Malaysia market regulatory submission.
• Familiar with QA requirements within pharmaceutical manufacturing.

Responsabilidades

• Develop and implement regulatory strategies to enable rapid approvals and launches.
• Maintain existing Product Licences with no negative impact on business targets.
• Monitor local and global regulatory changes and communicate implications to stakeholders.
• Manage regulatory support systems and coordinate with stakeholders.
• Foster cross-functional teamwork to support business strategies.
• Build an effective Regulatory Team.
• Ensure compliance with AZ GRP and industry codes, maintaining high regulatory standards.
• Develop strong relationships with Health Authorities and KEEs.

Conocimientos

Regulatory submissions experience

Quality assurance knowledge

Cross-functional teamwork

Regulatory compliance

Educación

Degree or equivalent in bioscience

Descripción del empleo

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.