Ronald Leung

International CMC for Actemra, Enspryng and Ocrevus

International filing for Actemra and Tecentriq (12months+ assignment)

Oversee regulatory affairs and quality assurance functions

Manage over 200 registered products including oncology, general medicine, vaccines and animal health products in the Hong Kong region Responsible for registration of New Chemical Entity (NCE) and ensure the best labelling, quick patient access.

As the Head of Validation and Regulatory Affairs, looking after the daily operations of these two departments. VALIDATION To support the development of required qualification/validation protocols and practices at the Europharm Lab to ensure compliance with GMP. To ensure the Europharm's facility and processes meet GMP, regulatory, and quality requirements with respect to all qualification/validation in line with company policies, VMP, and external standards such as Department of Health. REGULATORY AFFAIRS Responsible for new product application and apply for Change of Particulars (COP) in the Hong Kong market. To ensure finished product specifications, master formula and other registered particulars comply with Department of Health requirements.

Responsible for the aseptic compounding of chemotherapy medicines for Hospitals and Private Clinics in the North Island. Responsible for product release to ensure products meet GMP requirements, internal and external standards. To ensure the overall facility meets GMP and Medsafe standards. Manage product and customer complaints and assist in investigation.

Dispensing and Patient Counseling Methadone dispensing and prescribing Emergency Contraceptive Pill (morning after pill) Extemporaneous compounding and aseptic dispensing

Grade: First Class Honours Topic: Nanoparticles for Targeting Antibacterial Agent to Periodontal Pockets. Develop nanoparticles containing Triclosan to target periodontal pockets. Skills: In vitro release, particle analysis, UV spec, TEM