Job Description

Duties & Responsibilities To optimise regulatory strategies for new products and changes to existing products, aligned with business objectives To manage existing product portfolio life cycle, coordinate and participate in preparation of different types of regulatory submission to competent authorities for approval Cross-functional cooperation with R&D, Production, QA departments and external national health authorities Product submissions, registration and compliance to international regulatory standards by preparation and submission of technical dossiers (ICH) or technical files to regulatory authorities To ensure proper submission of documents to the health authority (NPRA) such as compilation of dossiers and preparation of production information and able to manage compilation and submission of responses to queries raised during the evaluation process of NDAs through coordination with relevant parties To ensure accurate reporting and compliance to the regulatory requirements To ensure all licenses are valid including company licenses, product licenses and authority certification for external partners such as GMP certificates and etc To keep abreast with the latest regulatory requirements and update the team if there is any potential impact on company operation Responsible for building and maintaining a credible relationship with regulatory authorities Review and approve product labeling for compliance with regional regulatory requirements Review scientific information to ensure the data is complete, sound, logical and supports the program goals To help the organization in Pharmacovigilance activities by providing product/drug safety data and documentation, performing of functional responsibilities like safety trend analysis, maintaining adverse reaction data, keeping global safety databases updated and conducting safety training Up-to-date and subject matter expert on all regulatory requirements (local, ASEAN, ICH, WHO), market insights Assists in Compliance, QA or pharmacovigilance activities wherever necessary Requirements Candidate must possess of Bachelor\'s Degree of Pharmacy, Science, Biotechnology or equivalent Licensed pharmacist with Pharmacy board of Malaysia Experience in Regulatory Affairs with strong track records, product registrations and life cycle management. Quality assurance experience would be an advantage An established candidate with a minimum of 5 years of experience in the Pharmaceutical industry Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies Have fluent oral and written communication skills in English Distinct opportunity to build and be involved in the growth and evolution of the company Promising opportunity to advance in an international company Willing to work beyond office hours when needs arise

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