Job Description

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. As the Head of Regulatory Affairs, you are responsible to lead the regulatory affairs team, to define the strategic direction and oversee the delivery of regulatory planning. You will also serve as a member in company leadership team. Key Responsibilities

• Oversee all operational aspects of regulatory affairs department including pipeline submission / approval plan, product license & lifecycle maintenance, regulatory compliance and company license-to-operate
• Establish Marketing Company Regulatory Affairs (MCRA) as a strategic partner to internal stakeholders including regional, international, global product/project teams
• Accountable for the successful execution of all stages of the regulatory process and implements strategies to improve quality and efficiency of submissions
• Provide strategic regulatory guidance and support to local leadership team, regional, international and global cross functional team
• Observe and pro-actively communicate the latest regulations, guidance and environment changes that may influence the landscape and assesses the potential impact on regulatory and/or business strategy and planning
• Optimise relationships with regulatory agencies, trade associations, and internal groups.
• Ensures compliance with departmental and company standard operation procedures and processes, organising training sessions and knowledge sharing seminars
• Accountable for the overall Marketing Company Regulatory Affairs Good Regulatory Practice (GRP) following AstraZeneca standard and external requirements
• Timely escalation of any internal/external emerging issues and oversee issue management handling related to regulatory affairs
• Serve and contribute as member of local company leadership team
• Lead and oversee the Patient Access Programme (PAP) for effective programme delivery to enhance patient care and improve patient access experience

Requirements

• Master\xe2\x80\x99s or Bachelor\xe2\x80\x99s Degree in Pharmacy, Science, or related discipline
• Substantial regulatory affairs experiences in pharmaceutical products, medical devices or relevant fields with sound knowledge of current regulatory environment
• Experience in leading team, or equivalent experience in managing teams through project management
• Strategic thinker with strong communication, organizational, negotiation and interpersonal 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.