Senior/Regulatory Specialist (Quality), TPB

[What you will be working on]

• Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approval to assure the quality of medicines supplied in Singapore
• 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
• Participate in projects and process/regulatory review

[What we are looking for]

• Background in Molecular Biology, Biochemistry, Chemistry, Pharmacy or related disciplines.
• Experienced in pharmaceutical manufacturing and quality control of biologics and / or chemical drug products
• Knowledge of drug development process and drug regulations
• Experience in the area of analytical assay development would be an advantage
• Good communication and interpersonal skills
• Good writing and presentation skills
• Able to analyse and integrate different sources of information to develop solutions
• Able to work independently as well as in a team
• Able to work effectively with people from other backgrounds, internal and external stakeholders
• Highly motivated