Regulatory Consultant (Quality), Therapeutic Products Branch

• 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.

• 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.