Assistant/Regulatory Manager, Therapeutic Products Branch

Health Sciences Authority; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A national health regulatory authority in Singapore is looking for a dedicated professional to contribute to therapeutic product registration. The role involves verifying documentation, managing application processes, developing procedures, and handling inquiries. Ideal candidates should have knowledge in Pharmaceutical Science or related fields, and familiarity with data analytics and Python coding is preferred. This is a unique opportunity to impact public health and safety.

Qualifications

• Knowledge in Pharmaceutical Science, Biomedical Science, Biotechnology, or related disciplines.
• Prior experience in data analytics and automation is an advantage.

Responsibilities

• Screen Applications: Verify documentation for new drug applications.
• Process Variation Applications: Manage post-approval changes for products.
• Develop Procedures: Collaborate to enhance registration services.
• Case Management: Track milestones for drug evaluation projects.
• Handle Procurement Matters: Collaborate with Corporate Service teams.
• Develop Automation and Data Analytics: Create tools for data analysis.
• Manage Enquiries: Respond to regulatory questions from stakeholders.

Skills

Knowledge in Pharmaceutical Science

Data analytics

Python coding

Education

Degree in Biomedical Science or related discipline

Job description

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 products 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 applications, and track key milestones for international collaboration projects on drug application evaluation.
• Handle Procurement Matters: Work with Corporate Service teams on procurement matters.
• Develop Automation and Data Analytics: Develop automation and data analytic tools to analyze 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 the public.

What we are looking for:

• 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 serving as the national regulator for health products, ensuring they meet safety, quality, and efficacy standards. It is also responsible for providing a safe and adequate blood supply and applying specialised scientific, forensic, investigative, and analytical capabilities in serving the administration of justice. For more details, visit http://www.hsa.gov.sg/. For updates on public health and safety matters, follow us on Twitter and LinkedIn.