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 a Regulatory Affairs Executive, you are responsible to implement regulatory strategies processes to ensure high-quality approvals and regulatory compliance, in order to achieve company’s business objectives and ensure existing product licenses are maintained to high standards.

Typical Accountabilities

• Apply regulatory strategies to achieve high quality approvals for new products and growth platforms.
• Execute submission strategies in collaboration with identified partners and optimise the balance between risk and commercial benefits.
• Process New Drug Registrations.
• Develop artwork required for packaging and coordinate with supply chain team to facilitate launch.
• Ensure effective delivery of regulatory submissions and approvals, including finding opportunities for earlier submissions and approvals.
• Close follow-up on the progress of submissions and approvals and keep related parties promptly informed.
• Maintain up-to-date knowledge and communicate changes in local regulatory environments.
• Effective management of the local and global regulatory support systems/information to ensure good coordination for all partners.
• Adherence to AZ values and Industry Code of Conduct, ethics, PhAMA Code and Good Regulatory Practices and ensure high standard of Regulatory Practices.
• Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement, guidelines, codes, policies and procedures.

Requirements

• You have a degree in Pharmacy, Life Sciences or in a related field.
• You have at least 2-3 years work experience in submitting NCE, line extension, maintaining product licenses, changing manufacturing sites and artwork.
• Familiar with local regulatory requirements & local Health Authority personnel.
• Experience in leading cross-functional team discussions and facilitating issue management, where required.

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.