Clarice Tsim

She is a regulatory affairs professional for more than 10 years of experience in drugs (including NCE, generic & OTC), food / health supplements and medical devices. She has worked for organisations with consolidated international presence such as Novartis, Bayer Healthcare and Fresenius Kabi with key approvals of Glivec (oncology), Exjade, Lucentis, Xarelto, Eylea (biologics) & Stivarga. Until recently, she led the regulatory consultants including distributors in Asia Pacific for submissions including the ACTD formatting & e-submissions. She is involved in the regulatory projects like due diligence / feasibility & product classification, license transfer, site change, CMC variations, market entry assessment, vendor selection and contract management in ASEAN ie Singapore, Thailand, Malaysia, Philippines, Cambodia, Myanmar, Vietnam, Indonesia, Laos. In addition she has the experience in setting up the QA system / QMS by preparing the quality manual and relevant SOPs or working instructions eg complaints & recall handling, repackaging, change management and self-inspection. She has also coordinated with the Global IT team for the development of the regulatory database system and documentum such as Amplexor, Liquent, VEEVA RIMS & eCTD Manager for APAC. She has a BSc (Pharmacology) from the University of Auckland, New Zealand.