AstraZeneca
Pharmaceutical
SeniorRegulatoryAffairsExecutive
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optimal for Senior candidates.
“Senior Regulatory Affairs Executive at AstraZeneca. Skills: Regulatory strategy, Product approvals, Health authority liaison. Develop and implement regulatory strategies. Achieve rapid and high quality approvals”
What You'll Achieve.
Zero negative impact to business objectives & financial targets
Industry & Context.
What They're Looking For.
Must Have
Degree or equivalent professional qualification in bioscience related field, Min. 2-3 years’ experience in Malaysia market submission, Familiar with quality assurance requirement within a pharmaceutical manufacturing environment
Nice to Have
Experience in pharmaceutical QMS requirement
What You'll Do.
Develop and implement regulatory strategies
Achieve rapid and high quality approvals
Facilitate rapid launch for new products
Maintain existing Product Licences
Monitor & interpret local & global regulatory environment
Communicate implications of regulatory changes
Manage local and global regulatory support systems
Ensure good coordination for all stakeholders
Contribute to optimum business strategies
Build an effective Regulatory Team
Adhere to AZ and Industry Code of Conduct
Ensure high standard of Regulatory Practices
Develop excellent relationships with Health Authorities
Ensure regulatory activities comply with AZ Good Regulatory
Conduct activities consistent with Company values
Complete all required training
Report potential issues of non-compliance
How You'll Work.
Team & Collaboration
Cross-functional teamwork; Coordination for all stakeholders
Full Job Description
**AstraZeneca** is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare: cardiovascular, diabetes, respiratory and cancer. At **AstraZeneca** we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to achieve our shared goals no matter where you start with us. **_Main Responsibilities_** * Develop and implement regulatory strategies to achieve rapid and high quality approvals and facilitate rapid launch for new products & growth platforms, to achieve the company’s business objectives. * Maintenance of existing Product Licences, with zero negative impact to business objectives & financial targets. * Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders. * Effective management of the local and global regulatory support systems/information to ensure good coordination for all stakeholders * Proactive cross-functional teamwork contributing to optimum business strategies. * Aid in building an effective Regulatory Team * Adherence to AZ and Industry Code of Conduct, ethics, PhAMA Code and Good Regulatory Practices (GRP) and ensure high standard of Regulatory Practices * Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs. * Ensure regulatory activities are perform in compliance with AZ Good Regulatory Practice. **_Typical Accountabilities_** * Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Regulatory Affairs * Complete all required training on the AZ Code of Conduct and supporting P
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