Regulatory Consultant (Quality), Therapeutic Products Branch

[What the role is]

Quality Evaluation of Therapeutic Products

[What you will be working on]

• Conduct scientific evaluation and lead evaluation strategies for biosimilar and biological products.
• Provide regulatory advice to industry on development and data requirements for biosimilar and biological products.
• Develop and implement regulatory frameworks for biosimilar assessment and biological product evaluation, which includes leading cross-functional technical discussions and providing strategic advice on complex submissions.
• Develop scientific opinions, position papers, and regulatory guidelines for biosimilars and biologics.
• Mentor and build technical capability within evaluation teams and lead strategic initiatives.
• Represent HSA at external engagements, including meeting with sponsors, technical and advisory committees.
• Foster partnerships with international regulatory authorities through collaborative review and information sharing activities.
• Serve as HSA's technical expert for workshare projects and represent HSA at international regulatory forums.

[What we are looking for]

• Background in Molecular Biology, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Pharmacy or related disciplines.
• Extensive experience in areas such as bioprocess engineering, pharmaceutical sciences, molecular therapeutics or biosimilars development would be an advantage.
• Minimum 12 - 15 years of experience in pharmaceutical manufacturing, quality control, or regulatory assessment of biologics.
• Leadership experience in biosimilar development processes, including oversight of comparability studies, analytical characterisation programs, and regulatory strategy development.
• Extensive experience in analytical method development and validation for biologics, including advanced techniques such as multi-attribute mass spectrometry (MAM), high-resolution characterisation of glycosylation patterns, and other cutting-edge characterisation methods.
• Experience in applying artificial intelligence and machine learning technologies to chemistry, manufacturing and control (CMC) aspects of drug development, including AI-driven process optimisation, predictive analytics for quality control, and statistical modelling of data for regulatory decision-making and risk assessment.
• Experience engaging with international drug regulators, with good understanding of biosimilar regulatory frameworks, guidelines, and emerging regulatory trends.
• Experience in team leadership, mentoring, and cross-functional project management within regulatory or quality assurance environments.
• Experience in regulatory policy formulation, guideline development, regulatory science initiatives, or contribution to international regulatory harmonisation efforts.
• Experience in stakeholder engagement at senior levels, including interactions with regulatory authorities, industry leadership, and international expert committees.

RELEVANT SKILLS

• Strong communication and interpersonal skills with ability to influence and guide technical discussions.
• Strong writing and presentation skills.
• Strong analytical and strategic thinking abilities to integrate complex scientific data and develop comprehensive regulatory strategies.
• Able to lead and manage teams and mentor junior staff effectively.
• Able to work effectively with people from other backgrounds, internal and external stakeholders.
• Highly motivated with strong desire to protect public health and safety.

• The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance.
• Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.