AstraZeneca is a leading global biopharmaceutical company. We believe the best way we can help patients is to focus on breakthrough science to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.

At AstraZeneca Malaysia, we aim to be the fastest growing pharmaceutical company in Malaysia in the therapeutic areas of cardiovascular, diabetes, oncology and respiratory. Through this ambition, we are confident that we can transform the lives of Malaysian patients by ensuring that they have access to life-changing medicines. Working here means being a member of our family in making a difference in delivering better health for Malaysian patients.

Job Description

As the Head of Regulatory Affairs and Quality Assurance, you are responsible to lead and define the strategic direction for regulatory affairs and quality assurance of the company.

Key Responsibilities

Regulatory Affairs

• Act as an expert resource to resolve complex regulatory issues and ensure the success of all elements of the regulatory process.
• Work as a partner within relevant product and project teams providing intelligence and advice, and strategic input as appropriate.
• Lead and drive projects through all stages of the regulatory process while providing advice.
• Accountable for the successful execution of regulatory process and implements strategies to improve quality and efficiency of submissions.
• Provide guidance and leadership regarding amended laws and regulations with emphasis on adherence with standard operating procedures and other corporate standards.
• Observe internal/external factors such as emerging regulation or shifts in regulatory enforcement and manage issues associated.
• Optimise relationships with regulatory agencies, trade associations, and internal groups.
• Ensure compliance with departmental and company standard operation procedures and processes, organise training sessions and knowledge sharing seminars.
• Lead and oversee the Patient Access Programme (PAP) for effective programme delivery to enhance patient care and improve patient access experience.

Quality Assurance

• Responsible for the company quality requirements and the establishment, lead the implementation of QMS and procedures across multiple GxP disciplines.
• Oversee the delivery of the entire QMS including auditing processes and reporting within area of scope.
• Lead quality initiatives and continuous improvement programmes aimed at ensuring compliance, enhancing commitment to quality and improving profitability.
• Act as the highest point of contact to resolve the most complex issues in quality assurance and collaborate with all key partners to reach a solution.
• Oversees the GxP compliance report and status being visible and communicated to key stakeholders and management team.
• Guide development of quality procedures across all GxP areas.
• Provides direction, development, and performance management to the country quality team.

Requirements

• You have a Master’s or Bachelor’s Degree in Science or related discipline.
• Substantial pharmaceutical experience, extensive knowledge of the drug development process inclusive of the regulatory processes.
• Good understanding of current regulatory environment and quality assurance within pharmaceutical environment.
• Highly developed leadership, excellent written and verbal communication skills.
• Proven project management skills.

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

Closing Date

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.