• Preparation and submission of necessary documents to FDA Drug Registration department to be accomplished On-Time.
• DRC approval On-Time before expiration date.
• Preparation and submission of necessary documents to FDA Medical Devices department to be accomplished On-Time.
• IR approval On-Time before expiration date.
• Preparation and submission of necessary documents to FDA to get DIAC approval On-Time before expiration date
• Preparation and submission of necessary documents to TMO (Township Medical Officer) & related government department to get WHOLESALE AND RETAIL SALES approval Certificate On-Time before expiration date
• Develop and maintain good relationship with local FDA and business partner (supplier/ manufacturer)
• Ensuring that goods and services are obtained at appropriate cost level and will meet regulation agency, suppliers, manufacturer satisfaction.
• Ensure that the quality standards are met and meet strictly the deadline of submission and approval
• Keep up-to-date with new regulation in local regulation as well as international regulation.
• Execute people management responsibilities by training, supervision and motivation
• Develops improvements on the quality of team output and individual performance
• Responsible for establishing Compliance policies and implementing processes

• MBBS, B.pharm, B.N. Sc, BDS, B.V.Sc, B.Med.Tech
• Minimum of 5 years as a Manager in Regulatory affairs department.
• Working knowledge and deep understanding of regulatory regulations procedures & laws (Local & International).
• Experience preparing and submitting regulatory application to government agency particular to FDA/MOHs.