Job Description

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world\xe2\x80\x99s most serious disease. But we\xe2\x80\x99re more than one of the world\xe2\x80\x99s leading pharmaceutical companies.

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace. Our culture of recognition and reward means each of us feels supported and empowered to step up and take responsibility.

In this role, you will lead to adopt Malaysia regulatory submission strategies and align with Frontier Market business objectives while adhere to AstraZeneca and industry codes of conduct, ethics & Good Regulatory Practices (GRP).

Key Accountabilities

• Maintenance of product licenses to the highest standard with zero negative impact to business objectives & financial targets
• Develop & implement regulatory plans to achieve rapid & high-quality approvals & facilitate rapid launch for Brunei, Cambodia & Bangladesh.
• Provide regional and global RA with support on matters that involve Brunei, Bangladesh and Cambodia.
• Supervise & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key partners
• Key liaison person to Brunei Health Authority on regulatory related matters including legal (including contracts) & patent-related matters
• Lead post approval implementation compliance on Brunei product supply
• Responsible for GRP supplier management
• Establishing and maintaining business continuity plans in the GRP area
• Support product market actions including product recalls where required.

Crucial Requirements

• You have a Degree qualification in bioscience or related field
• You have 2-3 years\xe2\x80\x99 experience in regulatory submission; preferably across Brunei market
• Familiar with quality assurance requirement within a pharmaceutical manufacturing environment

AstraZeneca is an equal opportunity employer. We 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. We only employ individuals with the right to work in the country/ies where the role is advertised.

Date Posted 12-Jul-2023

Closing Date 11-Ogo-2023

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.

AstraZeneca