• 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.
Rewards for over performance
- Opportunities for promotion
- Possibility for job training
- Learn new skills and techniques
We are a leading HR consultancy services in Asia Pacific with 25 years of industry experience and maintain our prime position via a strict commitment to high performance and unsurpassed industry knowledge. We offer to our clients, a personalized service that is delivered with the strictest of confidentiality. We pride ourselves as one of the most ethical and professional organisation in the HR industry.