REGULATORY AFFAIRS ASSOCIATE

LG Chem Life Sciences (Thailand) Ltd. (Pathum Wan)

Bangkok, Thailand

LG Chem is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials such as cathodes, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem is committed to reaching carbon-neutral growth by 2030 and net-zero emissions by 2050 by managing the impacts of climate change and making positive contributions to society through renewable energy and responsible supply chains.

Detail posisi

The Regulatory Affairs Associate is responsible for ensuring compliance with regulatory requirements, preparing and submitting necessary documentation, and supporting pharmacovigilance activities.

Kewajiban

• Perform appropriate regulatory evaluations in compliance with relevant requirements
• Prepare, submit and monitor license registration, variations, GMP clearance, and renewal
• Prepare and submit regulatory reports in compliance with relevant regulations
• Perform pharmacovigilance activities e.g., Adverse event reporting
• Update and maintain regulatory databases.
• Support FDA submission of promotional materials
• Other regulatory duties as assigned by the supervisor

Kualifikasi

• Bachelor's degree in pharmaceutical science with an active license
• Minimum 3 years of experiences in regulatory affairs
• Experience in bioequivalence study or pharmacovigilance area will be an advantage
• Proactive, quick learner, well organized and prioritized to fulfill requirements and timeline
• Able to achieve multiple tasks under pressure or committed timelines
• Able to work independently, at the same time a good team player
• Good interpersonal and effective communication skills
• Good command in English