ทักษะ:

GMP, English

ประเภทงาน:

งานประจำ

• Independently contribute to routine regulatory activities for product portfolio assigned.
• Responsible for registration of new products and line extensions as planned to ensure the launch plan for product portfolio will be as scheduled.
• Responsible for products license renewal, company's licenses, GMP clearance, and amendment.
• Maintain the registration licenses up to date throughout the lifecycle of products as required by local regulations and as data emerges, where applicable.
• Ensure all changes and quality issues relevant to regulatory activities are well-managed in accordance with internal procedures.
• Provide regulatory input / recommendation to ensure the compliance with current applicable regulatory affairs laws and regulations.
• Assist in reviewing labeling and promotional materials to ensure the compliance with regulatory requirements.
• Establish and maintain excellent working relationships with local health authority where applicable and other local regulatory agencies, as required.
• Where applicable, contribute in regulatory association's working groups and/or other regulatory projects from time to time with supervision from manager.
• Perform other duties required by superior from time to time.
• Bachelor's degree in Pharmaceutical Sciences.
• At least 5 years' experience in area of Regulatory Affairs responsible for pharmaceutical products.
• Good command in English particularly writing skill.
• Computer literacy-skill to use business applications.
• Actively responsible, well organized and able to work as a team with a positive attitude and open minded.
• Good collaboration with and communication to all relevant stakeholders.