Clinical evaluation of therapeutic product registration submissions
Evaluate the clinical data of therapeutic product applications for product registration to assure the safety and efficacy of medicines supplied in Singapore
Handle enquiries and requests from applicants, industry stakeholders and members of public
Participate in projects and process/regulatory review
Job Requirements
Possess knowledge and experience in related scientific disciplines, e.g., molecular biology, cell biologyy, immunology or related disciplines
Experience in the area of clinical research or medical practice would be an advantage.
Knowledge of clinical practice guidelines for different therapeutic areas
Knowledge of drug development process and drug regulations
Knowledge of international regulatory guidelines
Good communication and interpersonal skills
Able to work independently, as well as in a team
Able to work effectively with people from different backgrounds
Highly motivated with strong desire to protect public health and safety