Europe & Business Development Regulatory Affairs Specialist

Job Description

In this role, you will be responsible for regulatory activities for overseas markets, prepare and submit licensing documents, and ensure compliance with local regulations.

Requirements

• Graduated from Pharmacy, Chemical Engineering, Chemistry, Biology, or related departments
• At least 2 years of experience in the field of regulatory affairs
• Proficient in written and spoken English

Responsibilities

• Preparing and translating documents for license applications and renewals
• Coordinate document tracking for authority inquiries with internal departments
• Monitor relevant country regulations and revise files accordingly
• Ensuring documentation is properly prepared and sent in accordance with procedures
• Tracking process conduct by communicating with various countries