Senior Development Partner

• Nov 2019 - Present

Regulatory Specialist

• Aug 2017 - Oct 2019

• Evaluate quality aspects for regulatory submissions of new drug products, generic drug products, and post-market variation applications• Apply the principles of FDA, EMA, ASEAN and ICH guidelines, together with sound scientific background and benefits-risk assessment • Evaluate quality aspects for regulatory submissions of new drug products, generic drug products, and post-market variation applications• Apply the principles of FDA, EMA, ASEAN and ICH guidelines, together with sound scientific background and benefits-risk assessment

Senior Process Development & Technology Transfer Engineer

• Jan 2014 - Jul 2017

• Led technology transfer for business continuity with cross-functional local team• Influenced program strategy with global team (global regulatory affairs, global product leader and global supply chain), considering country regulatory requirements, supply chain and project timelines• Accountable for required data and documents for regulatory filing• Provided technical expertise for the manufacturing process and validation • Led process evaluation Design of Experiment with statistician and performed small-scale developmental runs • Worked closely with global experts on product knowledge and lifecycle management

Operations Engineer

• Jun 2010 - Dec 2013

• Involved in significant start-up activities for product transfer and change of manufacturing site• Prepared process validation documents for regulatory submission for manufacturing at the Singapore facility • Prepared compliance documents (validations, gap analysis and risk assessments for biologics manufacturing process)• Involved in Health Authority audits (HSA, ANVISA, EMA) and corporate audits (control room preparations and audit fronting)

Product Development

• Jun 2008 - Dec 2008

• Prepared annual reports for the review of infant formula produced for supply to various countries• Conducted 4 Pilot Plant trials to investigate production factors affecting product properties• Performed weekly lot matching of raw materials for the plant’s batch production to ensure the optimization of resources• Managed the department’s documents including product specifications and country regulations for infant formula • Prepared annual reports for the review of infant formula produced for supply to various countries• Conducted 4 Pilot Plant trials to investigate production factors affecting product properties• Performed weekly lot matching of raw materials for the plant’s batch production to ensure the optimization of resources• Managed the department’s documents including product specifications and country regulations for infant formula