Introduction to role:
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:
In this dynamic role, you will be responsible for:
- 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!
