Guardian Malaysia

Assistant Manager, Regulatory Affairs – Non Food (Health)

Posted: 12 hours ago

Job Description

Key Priorities & Challenges Main point of contact for all escalated Regulatory Challenges and liaison local authority. Support Regulatory Affairs Senior Manager for development, implementation of effective programs to monitor/manage regulatory shifts across our markets. Support the RA function to manage risk and ensure all new regulatory shifts that relate to Non-Food are managed effectively to ensure seamless transition. Support the RA function to develop and implement the appropriate control mechanisms to manage all local importations / indents and labelling requirements. Key Requirement:Keep abreast on regulatory updates in ASEAN (Malaysia, Singapore, Brunei, Philippines, Indonesia, Vietnam and Cambodia) for health categories. Support product registration and importation for health categories for ASEAN markets. Manage registration submission, product legal classification, registration dossier/ CSDT review, claims checking etc.Manage authorities’ correspondence on product registration. Ensure Own Brand products selling in the markets are complying with the local regulatory requirements. Provide weekly updates on emerging market. Provide monthly updates on emerging market. Monitoring all markets product license validity and controversial ingredient and provide sufficient support and guidance for all the product registration in all markets. Review all the product claim related marketing material to ensure full regulatory compliance. Education: Required: Bachelor's Degree in Pharmaceutical, Chemistry, Chemical Engineering or related sciences.Experience: Required: At least 3-5 years’ experience in regulatory affairs and / or quality assurance for healthcare products (medical device, health supplement, OTC, etc). Experience in product registration for emerging markets will be an added advantage.Competencies: Proficient knowledge of health and beauty related legislation for emerging markets, health and beauty claims and labelling requirementsEffectively implement the Standard Operating Procedures that deliver QA processes to meet Group Own Brand standardsExcellent organizational and prioritization skills with the ability to manage multiple projects with demonstrated flexibility and adaptabilityDemonstrated problem solving and decision-making skillsExcellent oral and written communication skillsExcellent interpersonal skills and being a team playerProficiency with Microsoft office (all aspects), especially Microsoft Excel for report preparation

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