Assistant/Regulatory Manager, Therapeutic Products Branch

[What the role is]

Screen applications to register therapeutic products, manage cases and enquiries, and improve processes.

[What you will be working on]

• Screen Applications: Verify that required documentations for new drug applications and generic drug applications meet the submission requirements for evaluation.
• Process Variation Applications: Process applications for post-approval changes to registered therapeutic product as part of product lifecycle management.
• Develop Procedures: Collaborate with the team to establish procedures for new services or enhance existing services related to therapeutic product registration.
• Case Management: Coordinate the submission, manage application and track key milestones for international collaboration projects on evaluation of drug applications.
• Handle Procurement Matters: Work with Corporate Service teams on procurement matters.
• Develop Automation and Data Analytics: Develop automation and data analytic tools to analyse databases and generate insightful reports.
• Manage Enquiries: Manage enquiries related to regulatory requirements and procedures for therapeutic product submissions from industry and healthcare stakeholders, as well as general enquiries from members of public.

[What we are looking for]

• Possess Knowledge in Pharmaceutical Science, Biomedical Science, Biotechnology or related disciplines.
• Prior experience with data analytics, automation and python coding is an advantage.
• Prior work experience is not a requirement.