---

Detail posisi

The Regulatory Affairs and Quality Compliance Executive will be responsible for coordinating with various departments to ensure compliance with regulatory requirements, managing product registration processes, and overseeing quality system procedures.

Kewajiban

• Cross-functional co-ordinate with other departments to conduct the complaint management and vigilance system according to B. Braun Global policy and regulatory requirement
• Assist in developing, preparing, implementing and maintaining quality system procedures according to standards and regulations under the guidance of manager and consultant
• Ensure all activities of BBTH including registration activities are complied with Law and Regulation
• Co-ordinating with relevant parties to support clinical trials and clinical activities including the submissions and supporting the sites
• Co-ordinate with other departments and the manufacturer to get the registration dossier/additional documents for registration/renewal/variation as required by B.Braun (Thailand) Ltd. and to provide sufficient lead time
• Compile and prepare registration dossier to meet country requirements for submission to authorities
• Participate in registration planning, arranged with the local marketing or Regional/Global RA
• Negotiate with authorities
• Manage registration renewal
• Follow up/monitor process of evaluation at authorities
• Handle objections/additional requests of the authorities
• Translate package insert into Thai version or modify packaging material provided by the global team
• Receive and keep original registration license
• Conduct and compile the Safety Monitoring Program for product required
• Co-ordinate with authorities to conduct any local studies e.g. Clinical studies, Bio-equivalence studies, etc. as per Health Authorities or Company request
• Update and maintain registration requirement
• Update and maintain registration status
• Involve in FDA discussion and monitoring on new regulations
• Manage annual renewal of license for sales and license for importation
• Apply for amendment of licenses such as licensee name, warehouse, relocation, time, etc in accordance with the rules, procedures and conditions prescribed in Ministerial Regulations
• Apply for a replacement licenses and certificates of drug registration
• Apply for revision of registration file in accordance with the change of licenses
• Manage the report of product import and sale complied with the relevant regulation
• Request the FDA permission to advertise Pharmaceutical/Biological Products/Cosmetic/Medical Devices (B.Braun products) in Thailand
• Regulate to use label, package insert and Certificate of Analysis corresponding to the formula registered or the pharmacopoeia notified by the Minister under Section 76(1) of Drug Act
• Manage to have retain sample of product importation for FDA investigation as prescribed in the Ministerial Regulation
• Exercise control over labeling in accordance with Health Authority Regulation
• Exercise control over importation and sale of B.Braun products to insure compliance with the pertinent raw and regulation
• Ensure the compliance to regulation and approved protocol for studies conducted in the territory
• Communicate with the global comp

Kualifikasi

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Medical Sciences, or related fields
• At least 3 years of experience in Regulatory Affairs and Quality Compliance in the pharmaceutical or medical device industry
• Knowledge of Thai Drug Act, Medical Devices Act, and other Ministerial regulations
• Experience in managing product registration processes and renewals
• Strong communication and negotiation skills
• Ability to work cross-functionally with various departments
• Attention to detail and ability to ensure compliance with regulatory requirements
• Fluency in Thai and English languages
• Strong organizational and time management skills