Senior/Regulatory Specialist/Regulatory Consultant, Innovation Office & Clinical Trials Branch

[What the role is]

The Health Products Regulation Group (HPRG) of HSA ensures that medicines, innovative therapeutics, medical devices and health‐related products are wisely regulated and meet appropriate safety, quality and efficacy standards. HPRG contributes to the development of biomedical sciences in Singapore by administering a robust, scientific and responsive regulatory framework.

The Innovation Office and Clinical Trials Branch (IOCTB) of HPRG is responsible for the regulation of clinical trials in Singapore. In addition to the evaluation of clinical trial applications, the Innovation Office provides early regulatory consultations to companies and researchers to facilitate
efficient innovative therapeutic product development.

We are looking for an experienced and qualified medical doctor to join the Innovation Office and Clinical Trials Branch. Working as a core member of a cross-functional team, the Senior / Regulatory Specialist / Consultant provides/leads the provision of regulatory and scientific advice to stakeholders, and conducts/leads the medical and scientific review of clinical trial applications to support the safe use of investigational products in clinical trials, facilitate innovative product development and enable timely product approval in Singapore.

As the regulatory landscape modernises, an interest and competency in digital health, artificial intelligence (AI), and tech-driven solutions will be a significant advantage, enabling the branch to evaluate advanced trial methodologies and drive innovation to increase the efficiency of internal operations.

Beyond application reviews, the individual is expected to contribute to regulatory policy and guidance review and development, day-to-day operational excellence, and the execution of key branch projects. The individual is also expected to keep abreast of rapid scientific and clinical advances, and contribute to professional networking, regulatory collaborations, and partnerships at national, regional, and international levels.

[What you will be working on]

• Provide/lead regulatory, medical and scientific advice to stakeholders as part of the Innovation Office to facilitate efficient development of innovative therapeutic products.
• Conduct/lead medical and scientific review of clinical trial applications, including the evaluation of safety data and adverse events; provide cross-branch support for therapeutic product evaluations when required.
• Contribute to stakeholder training, communication and engagement
• Lead/contribute to regulatory policy and guidance review and development, efficient and effective operations, and implementation of branch projects, including the adoption of digital tools and automation to drive operational efficiency.
• Keep abreast of emerging scientific and medical advances relating to novel technologies, digital health and product types with a view to provide relevant strategic and scientific inputs to ensure the regulatory framework is responsive to emerging developments.
• Represent Singapore’s interest and contribute to networking, development of harmonised technical guidance, regulatory collaborations and partnerships at national, regional and international levels.

[What we are looking for]

• Relevant medical background
• 2–10 years’ clinical practice experience in a hospital or clinic setting, and/or regulatory or scientific experience in the non-clinical, quality, or clinical development of therapeutic products in the pharmaceutical industry or academia.
• Knowledge of the drug development process, regulatory requirements, GCP (Good Clinical Practice) guidelines and other relevant drug development scientific guidelines
• Experience and expertise in scientific disciplines relevant to drug development, such as medical review, clinical pharmacology, toxicology, immunology, molecular biology, precision medicine, regulatory science, model‐informed drug development, adaptive / innovative trial design and statistics would be an advantage.
• Familiarity with the local biomedical sciences and healthcare landscape would be an advantage
• A strong interest, competency, or track record in utilising digital tools, data analytics, or automation to optimise workflows, with prior experience in developing or implementing such systems considered a significant advantage.
• Able to think critically and strategically, with good analytical skills to analyse, interpret and communicate technical data effectively.
• Able to communicate effectively, confidently and diplomatically with various stakeholders
• Able to work collaboratively with internal colleagues, as well as engage external domain experts and stakeholders effectively.
• Able to facilitate or lead meetings, make effective presentations, and organise forums.
• Able to lead projects to deliver results, and prioritise work according to timelines.
• Proactive and self‐directed as a learner, with the capability to work in a fast-paced environment.
• Forward-looking in embracing and driving the use of digital tools