ADIGE is seeking a Regulatory Affairs Executive to join our team. This role involves preparing, submitting, and managing drug registration dossiers in accordance with Vietnamese pharmaceutical regulations. This position is open to fresh graduates who are eager to learn and grow in the pharmaceutical regulatory field.

Key Responsibilities

• Prepare and compile registration dossiers for pharmaceuticals in line with local regulations (eCTD/ACTD format).

• Submit dossiers to the Drug Administration of Vietnam (DAV) and follow up on approvals.

• Work closely with manufacturers and suppliers (local and overseas) to gather and verify documentation.

• Stay updated on regulatory changes and ensure compliance.

• Maintain accurate records of product registration status and related communications.

• Support activities related to license renewals, variations, and post-approval changes.

• Collaborate with internal QA/RA teams on product labeling and documentation compliance.

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related field.

• Open for Fresh graduates.

• Strong attention to detail and good organizational skills.

• Basic understanding of Vietnamese pharmaceutical regulations is an advantage.

• Proficiency in MS Office (Word, Excel, Outlook).

• Good communication skills in both Vietnamese and English.