Senior Regulatory Affairs Executive

Tasks & responsibilities

• Responsible for the overall registration, coordination, implementation, execution, and completion of product registration for all products, assuring compliance with regulatory requirements in Thailand.

• Handle regulatory activities throughout product life-cycle (product registration and post-approval variation)

• Apply a promotional material application in order to support business for marketing activities and to ensure to comply by law.

• Manage packaging component artwork of registered products and ensures timely implementation and compliance with relevant regulations/ registered details as well as company internal process

• Apply a Certificated of lot release application for biological and vaccine product to ensure product can be ready for sale on time.

Requirements

• At least three years experienced in regulatory affairs knowledge of pharmaceutical areas.

• Bachelor's degree or equivalent in pharmacy. Additional education in management is beneficial.

• Good for English language skills.