Assistant/Regulatory Manager, Therapeutic Products Branch

2 weeks ago


Singapore Health Sciences Authority Full time

Description Assistant/Regulatory Manager, Therapeutic Products Branch Join to apply for the Assistant/Regulatory Manager, Therapeutic Products Branch role at Health Sciences Authority (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. Seniority level: Entry level Employment type: Full-time Job function: Other #J-18808-Ljbffr Industry Other Category Management & Operations Sub Category Product Management



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