Senior Regulatory Affairs Executive - Brunei, Cambodia and Bangladesh

AstraZeneca (Malaysia); Selangor; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a Senior Regulatory Affairs Executive to oversee regulatory submission strategies for Malaysia, Brunei, Bangladesh, and Cambodia. The role requires at least 2-3 years of experience with a bioscience-related degree and emphasizes compliance and regulatory excellence. Join us in making a difference in healthcare by ensuring high-quality approvals and improving patient access to transformative medicines.

Qualifications

• Minimum 2-3 years’ experience in Brunei market regulatory submission.
• Familiarity with quality assurance requirements within a pharmaceutical manufacturing environment.

Responsibilities

• Adhere to industry codes of conduct and Good Regulatory Practices.
• Maintain product licenses and ensure compliance.
• Develop and implement regulatory plans for approvals.
• Act as key liaison with Health Authorities on regulatory matters.
• Monitor compliance and manage GRP supplier relationships.

Skills

Regulatory submission strategies

Cross-functional teamwork

Compliance management

Communication with Health Authorities

Monitoring regulatory environments

Education

Degree in bioscience-related field

Job description

Senior Regulatory Affairs Executive - Brunei, Cambodia and Bangladesh

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Are you ready to make a significant impact in the pharmaceutical industry? As a Senior Regulatory Affairs Executive, you will play a crucial role in adopting and executing regulatory submission strategies for Malaysia, Brunei, Bangladesh, and Cambodia. Your expertise will ensure high-quality approvals and regulatory compliance, maintaining Good Regulatory Practices (GRP) in line with AstraZeneca standards and external regulations. This is your chance to contribute to the rapid launch of transformative medicines and improve patient lives across diverse markets!

Accountabilities

• Adhering to AstraZeneca and industry codes of conduct, ethics, and Good Regulatory Practices.
• Maintaining product licenses to a high standard, ensuring no negative impact on business objectives and financial targets.
• Developing and implementing regulatory plans for rapid and high-quality approvals.
• Monitoring and interpreting local and global regulatory environments for significant changes, communicating implications to key stakeholders.
• Engaging in proactive cross‑functional teamwork to contribute to optimum business strategies.
• Acting as the key liaison with Health Authorities on regulatory matters.
• Managing legal and patent‑related matters.
• Monitoring post‑approval implementation compliance for Brunei product supply.
• Managing post‑approval implementation for Bangladesh and Cambodia.
• Ensuring GRP areas under responsibility comply with external regulations.
• Identifying compliance risks and following up on issues.
• Conducting GxP self‑assessments in the GRP area.
• Monitoring KPIs in the GRP area and proposing remedial actions.
• Managing GRP supplier relationships.
• Monitoring internal/external factors such as emerging regulations or shifts in regulatory enforcement.
• Identifying trends and communicating identified risks.
• Establishing and maintaining business continuity plans in the GRP area.
• Supporting product market actions, including product recalls when required.
• Reviewing and approving promotional and educational materials to ensure regulatory compliance.

Essential Skills & Experience

• Degree or equivalent professional qualification in bioscience‑related field.
• Minimum 2‑3 years’ experience in Brunei market regulatory submission.
• Familiarity with quality assurance requirements within a pharmaceutical manufacturing environment.

Desirable Skills & Experience

• Experience in pharmaceutical Quality Management System (QMS) requirements.

AstraZeneca offers an environment where you can seize the opportunity to improve the lives of millions of patients, especially in areas where needs are often unmet. Our transformative pipeline brings high‑quality medicines to market, ensuring they are accessible to as many patients as possible. With a culture that fosters learning, development, and collaboration, you will be empowered to embrace challenges and contribute to meaningful change. Join us in our mission to power a better future through courage, innovation, and a commitment to excellence.

Ready to make a difference? Apply now and become part of a team that is shaping the future of healthcare!

Date Posted

27-Nov-2025

Closing Date

30-Dec-2025

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.