Assistant/Regulatory Manager, Therapeutic Products Branch

[What the role is]

[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.