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Subang Jaya

    Senior Regulatory Affairs Executive - Petaling Jaya, Malaysia - AstraZeneca

    AstraZeneca
    AstraZeneca Petaling Jaya, Malaysia

    Found in: Talent MY C2 - 1 day ago

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    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's most serious disease. But we're more than one of the world's leading pharmaceutical companies.

    At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's 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' 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.

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