Job Purpose:Responsible for ensuring timely submission of pharmaceutical products and/or medical devices new registration, re-registration, change notification (updating registered particulars of products inclusive of site transfers) in ASEAN and Global Region (as per existing/new business) so that business is not unduly interrupted.Responsible to attend and/or to participate in any post-registration activities such as post-market surveillances, customer enquiries, and regulatory-related pharmacovigilance activities (where applicable).Engaging internal and external stakeholders to provide regulatory strategy and support within applicable context.Responsible to maintain close liaison with ASEAN National Regulators, Industry Associations, local government officers (State and Federal Pharmacy Enforcement officers, National Pharmaceutical Regulatory Agency (NPRA) and Medical Device Agency (MDA)), for all matters pertaining to product registration and regulatory.Key Accountabilities:Maintain current knowledge of relevant regulations and guidelines, and to communicate regulatory information to related departments and Management of latest updates on requirements and guidelines.Responsible for compilation and submission of product dossiers with regards to pharmaceutical/medical device product registration to ASEAN/International regulatory authorities and to follow through the pharmaceutical/medical device product registration correspondence until registration approval.Responsible for compilation and submission of pharmaceutical/medical device product dossier for change notification submission to ASEAN/International regulatory authorities and its approval to ensure business continuity.Responsible to monitor all regulatory information received from relevant authorities and communicated to stakeholders where required and executed within the deadline as set by the authorities.To review product artwork registered in ASEAN/International countries to ensure compliance to applicable regulatory requirements.To assist Manager in ensuring compliance with local and ASEAN/International regulatory requirements for Pharmaceutical, Medical Device and Cosmetic products.Responsible in addressing and responding in a timely manner for any requests, queries or correspondences, from ASEAN/International region in terms of regulatory.To provide support and assist Manager for both internal and external audits, i.e., ISO Audits, GMP and GDPMD audits conducted by relevant Regulatory Authorities, including NPRA, Medical Device Agency (MDA) as and when required.To provide on-the-job training and guidance as and when required to staffs to ensure they attain minimum competency to perform the required tasks.Any other duties that may be assigned by Management from time to time.Requirement:Possess at least a Degree in Science (Preferably Pharmacy) or any other related field of study.Minimum 5 years of experience in regulatory compliance activity in pharmaceutical.DRGD, MVG, and ACTD regulatory knowledge.Relevant computer skills in Microsoft and Adobe.Proactive, Strong teamwork and team building skills.Ability to strategize and execute tasks in a timely manner without compromising the quality of deliverables.Ability to build relationships and communicate effectively with stakeholders of all levels.