Job Description

Job Summary - Clinical evaluation of cell, tissue and gene therapy product (CTGTP) registration submissions

Work Location: Helios, 11 Biopolis Way, Singapore 138667

Responsibilities

Conduct robust clinical reviews of CTGTP applications based on appropriate standards of safety, quality and efficacy within the targeted timelines and provide recommendation for regulatory decision of product applications

Provide advice / guidance to industry stakeholders on the requirements and procedures for cell, tissue and gene therapy product regulatory submissions

Participate in projects and process/regulatory review (including but not limited to regulatory and legislative policies, technical standards and guidelines)

Be a technical liaison with other regulatory authorities or relevant bodies for exchange of regulatory information

Requirements

Possess knowledge in related scientific disciplines, e.g., biomedical sciences, pharmacy, molecular biology, cell biology, immunology

At least 5 years of relevant experience in cellular immunology, cell therapy, cell biology, cancer biology, molecular biology or regulatory experience in CTGTPs. Experience in medical practice or clinical research in CTGTPs is advantageous.

Highly motivated with strong desire to protect public health and safety

Able to work effectively with others with diverse backgrounds and with officers from other branches to foster a culture of collaboration

Specific skills:

o Knowledge of basic biostatistics and interpretation of clinical data

o Knowledge of clinical development process for CTGTPs

o Good understanding of current international regulatory landscape in the field of CTGTPs

o Good communication and interpersonal skills