Malaysia onlyAbout us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing,and Cambridge, U.S. To learn more about BeOne, please visitwww.beonemedicines.comand follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
The Regulatory Affairs Associate is responsible for ensuring the regulatory compliance of therapeutic products in Australia and New Zealand, through clinical trial applications and notifications, supply reports, GMP applications and import/export permit applications.
Essential Functions of the job:
Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
Prepare, submit and support clinical trial applications and variations in Australia and New Zealand.
Submit GMP renewal and variation applications for Australia.
Collate and submit supply reports for Australia.
Arrange for import/export permits for products to move in and out of Australia.
Develop and maintain standard operating procedures or local working practices.
Maintain current knowledge of relevant regulations, including proposed and final regulations.
Supervisory Responsibilities:
Does not include supervisory responsibilities.
Qualification Required:
Education Required:
Life sciences degree
Computer Skills: Microsoft Office Applications
Other Qualifications:
Excellent organisational and communication skills
Experience of working on regulatory applications, including clinical trial notifications/applications, for Australia and/or New Zealand would be a plus
Travel: Minimal
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
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