Screen applications to register therapeutic products, manage cases and enquiries, and improve processes.
Assistant/Regulatory Manager, Therapeutic Products Branch
Health Sciences Authority
Fixed Terms
Closing in 1 day(s)
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
- 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.
About Health Sciences Authority
The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety. HSA is a multidisciplinary authority. It serves as the national regulator for health products, ensuring they are wisely regulated to meet standards of safety, quality and efficacy. As the national blood service, it is responsible for providing a safe and adequate blood supply. It also applies specialised scientific, forensic, investigative and analytical capabilities in serving the administration of justice.
For more details, visit http://www.hsa.gov.sg/.
For more updates on public health and safety matters, follow us on Twitter at www.twitter.com/HSAsg and LinkedIn at https://sg.linkedin.com/company/health-sciences-authority.
About your application process
This job is closing in 1 day(s).
If you do not hear from us within 4 weeks of the job ad closing date, we seek your understanding that it is likely that we are not moving forward with your application for this role. We thank you for your interest and would like to assure you that this does not affect your other job applications with the Public Service. We encourage you to explore and apply for other roles within Health Sciences Authority or the wider Public Service.