Job Description

What the role is: Summary
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 individual to join the Innovation Office and Clinical Trials Branch. The Senior / Regulatory Specialist provides/leads the provision of regulatory and scientific advice to stakeholders, and conducts/leads the conduct of the scientific review of data to support the safe use of investigational products in clinical trials, to support innovative product development and to support product approval in Singapore. The individual is also expected to contribute in regulatory policy and guidance review and development, efficient and effective operations, and effective implementation of projects in the branch. The individual is expected to keep abreast of scientific advances and contribute to networking, regulatory collaborations/partnerships at national, regional and international levels.Core responsibilities include:

• Provide/lead regulatory and scientific advice to stakeholders as part of the Innovation Office to facilitate efficient development of innovative therapeutic products.
• Conduct/lead scientific review and provide recommendations on clinical trial applications and new drug applications in Singapore.
• Contribute to stakeholder training, communication and engagement
• Contribute/lead regulatory policy and guidance review and development, efficient and effective operations, effective implementation of projects.
• Keep abreast of emerging scientific advances relating to novel technologies and product types with a view to provide relevant strategic and scientific inputs to ensure regulatory framework is responsive to emerging developments
• Represent Singapore\'s interests and contribute to networking, development of harmonised technical guidance, regulatory collaborations and partnerships at national, regional and international levels.

Job Requirements

• Possess knowledge and experience in related scientific disciplines, e.g., Medicine, Pharmacy, Pharmacology, Toxicology, Immunology, Infectious Diseases/Microbiology, Oncology, Genomics/Precision Medicine, Cell, Tissue and Gene Therapies, Biomedical/Biological/Health Sciences

Experiences

• 2-10 years\' regulatory and/or scientific experience in the non-clinical, quality and/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 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 landscape would be an advantage

Personal attributes

• Critical and strategic thinker with good analytical skills. Able to analyse, interpret and communicate technical data effectively.
• Demonstrates ability to facilitate or lead meetings, make effective presentations, organize forums and engage collaboratively and effectively with internal and external stakeholders
• Effective oral and written communication skills. Able to communicate confidently and diplomatically with various stakeholders
• Able to engage and work effectively with external domain experts where necessary
• Ability to lead projects to deliver results
• Self-directed learner, proactive and able to work in a fast- paced environment
• Able to prioritize work according to timelines.

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.

Health Sciences Authority