Job Description

Basic medical/pharma/scientific knowledge that can be applied in developing regulatory submission documents Thorough knowledge of major HA global/regional/national country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management Markets Handled: Australia, Cambodia, Hong Kong, Korea, Malaysia, Macao, Indonesia, Pakistan, Philippines, Singapore, Taiwan Thailand, Vietnam Prepare and compile global regulatory dossiers in ACTD, eCTD and non eCTD format in accordance with ASEAN HA legislations and client specific requirements Prioritise, plan, and monitor submissions for allocated products while documenting and informing involved parties of progress Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications Hands-on experience on regulatory document management systems and publishing tools Able to create submission packages in line with regulatory strategy for pharmaceutical drugs, vaccines, generics, GMO s, and biological products Coordinate with cross-functional teams, including RD, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation Regular tracking and maintaining the submission trackers Stay updated with evolving regulatory requirements and industry trends and able to extract regulatory intelligence information (requirements for initial filing, drug/device/cosmetic/food registration etc) Participate in trainings and learn through hands-on experience on the job Exhibit flexibility in moving across new projects and preparing multiple document types Continuously enhance and maintain knowledge of various regulatory guidelines for different deliverables by doing various assignments Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest EDUCATION: BPharm / MPharm/ Pharm D/ MSc EXPERIENCE: Required 2-4 years of experience in ASEAN markets

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