[What the role is]
Clinical evaluation of therapeutic product registration submissions
[What you will be working on]
- Evaluate clinical data submitted by pharmaceutical companies and provide technical advice on data requirements for therapeutic product registration applications.
- Develop scientific opinions and position papers on evolving regulatory approach and technical requirements.
- Represent HSA at external engagements, including meeting with sponsors, technical and advisory committees.
- Foster partnership with international regulatory authorities through collaborative review and information sharing activities.
- Serve as HSA's technical expert and front scientific discussions for workshare projects with international regulators.
- Represent HSA at international regulatory forums, contributing to development of regulatory guidelines and standards.
[What we are looking for]
A bac...