Regulatory Affairs & Quality Manager

About this position

Responsibilities

Regulatory Affairs:
• Managing the product registration and product life cycle
• Provide Thailand registration strategy and execution plan
• Manage the regulatory affairs team to have the registration approved on time
• Review and approve packaging artwork, advertising, and labels to ensure that products placed on the Thai market meet local regulatory requirements
• Develop subordinated employees and carry out individual personnel measures
• Maintain all regulatory files for all products in accordance with health authority requirements and timelines including
• Consolidate, validate, and track regulatory dossiers prior to registration
• Maintaining regulatory files for all product renewals and extensions
• Plan, coordinate, and manage for the lot release to be ready for sales time
• Development/ maintain relationships with relevant internal and external parties
• Providing advice and advance warning on potential regulatory risks and proposing preventive or corrective measures.

Quality:
• Ensure that the current quality management system is established and maintained to regular meet the standard and regulatory requirements of the company and government concerns.
• Ensure that the quality system and good distribution practices (GDP) are clearly specified and updated by procedure and adequate training for all employees.
• Ensure that all technical problems affecting the quality of products are investigated and solved in a timely by coordinating with the manufacturer and distributor supplier.
• Ensure that the quality finished products are met the standard requirements of the company and regulatory authority.
• Regulatory Affairs & Quality Manager is appointed as Quality Management Representative (QMR) and responsible for ensuring that the requirements of the quality management standard are established, implemented, maintained, and improved.
• Plan and coordinate regular audits on the quality system to ensure continued adherence to documented requirements.
• Reporting the performance of the quality system to the management for review once a year.
• Ensure that the product quality and processing are fulfilled to regulatory requirements and ensure that all deviations, out-of-specification (OOS) results, customer complaints are properly evaluated and approved on changes impacting product quality and safety

Pharmacovigilance:
• To ensure the establishing, implementing, and maintaining: a pharmacovigilance system. And safety issues of pharmaceutical products including medical devices.
• Ensuring the PV reports, device defect/AE reports are prepared and submitted in a timely manner as defined by Safety Data Exchange Agreement with LG Chem Head Office and local regulations.
• Manage to answer requests from Health Authorities.

Requirements

Qualification:
• Bachelor’s in Sciences of Pharmacy (or higher degree will be an advantaged)
• Fluent in English Speaking, Writing and Reading (Business Level)
• At least 5 – 8 years of experience in Regulatory Affairs and other related experiences in the Pharmaceutical Business is a must.
• Solid knowledge of product regulation, guidelines, and standard
• Experience working for multi-national companies.