The Regulatory Consultant position at tech.gov.sg focuses on the quality evaluation of therapeutic products, particularly biosimilars and biological products. The ideal candidate will have extensive experience in pharmaceutical manufacturing and regulatory assessment, along with a strong background in molecular biology or related fields
Job Summary
Conduct scientific evaluation and lead evaluation strategies for biosimilar and biological products.
Develop and implement regulatory frameworks for biosimilar assessment and biological product evaluation.
Represent HSA at external engagements, including meeting with sponsors, technical and advisory committees.
Matching Summary
Match Score: 85
The Regulatory Consultant position at tech.gov.sg focuses on the quality evaluation of therapeutic products, particularly biosimilars and biological products. The ideal candidate will have extensive experience in pharmaceutical manufacturing and regulatory assessment, along with a strong background in molecular biology or related fields.
Skills & Requirements
Must-have
biosimilar and biological products evaluation
regulatory frameworks development
scientific opinions and position papers
analytical method development and validation
AI/ML in CMC drug development
international regulatory forums representation
Nice-to-have
strong desire to protect public health
foster partnerships with international authorities
stakeholder engagement at senior levels
Key Requirements
12-15 years of experience
Molecular Biology, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Pharmacy or related
Leadership experience in biosimilar development
Experience engaging with international drug regulators