Regulatory Affairs Executive

• Maintenance of product licenses to a high standard throughout current year, with zero negative impact to business objectives and financial targets.
• Support and coordinate regulatory activites across the product lifecycle, including the preparation, compilation, delivery, and maintenance of regulatory submissions to achieve rapid and high quality approvals.
• Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs.
• Proactive cross-functional teamwork contributing to optimum business strategies.
• Effective management of the local and global regulatory support systems/information to ensure good coordination for all stakeholders.
• Ensure adherence to AZ and Industry Code of Conduct and Ethics while performing regulatory activities.
• Provide guidance and functional support to regulatory team members to build an effective Regulatory Team.
• Ensure regulatory activities are performed in compliance with AZ Good Regulatory Practice.

• 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.

• Pharmacy or Scientific Degree or equivalent professional qualification in related field.
• Post-graduate qualification.
• Experience in quality assurance within a pharmaceutical manufacturing environment.
• Minimum 1-2 years of experience in Malaysia market regulatory submissions.
• Familiar with local regulatory requirements and local Health Authority personnel.

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.