[What the role is]
The Assistant Regulatory Manager/ Regulatory Manager of Therapeutic Products Branch will 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]
- Background 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.