What the role is:The post is for the Senior Regulatory Executive / Assistant Regulatory Manager, Therapeutic Products Branch.
The post is to manage product registration applications and the registration management system.1) To work with the team on setting up procedures for new services or improving existing services for therapeutic product registration.2) To manage cases for registration applications (case manager), which includes international work sharing activities.3) To screen new drug applications and generic drug applications and assess proposed changes in minor variation therapeutic product applications for registration.4) To work with the team on post-registration management system for TP registrations, including management of registry, IT systems, procurement and finance matters related to the unit.5) To manage databases and generate periodic reports.6) To provide advice/ guidance on the regulatory requirements and procedures for therapeutic product regulatory submissions, and to respond to enquiries from industry and healthcare stakeholders as well as member of public.7) To work with the team on policies related to therapeutic product registration.Job RequirementsPossess knowledge and experience in related scientific disciplines, e.g. Pharmaceutical Science, Biomedical Science, Biotechnology or related disciplines.Prior experience with data analytics, automation and python coding will be an advantage.Prior work experience is not a requirement.Good communication and interpersonal skillsAble to work independently, as well as in a teamAble to work effectively with people from different backgroundsHighly motivated with strong desire to protect public health and safetyAbout 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.
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