Internship Regulatory Administrator

KOTRA PHARMA (M) SDN BHD; Malacca City; On-site; MYR 56,000 - 100,000; Full time

Job summary

KOTRA PHARMA (M) SDN BHD is seeking a regulatory affairs assistant in Malaysia, focusing on local and overseas product registration documentation. The role involves assisting in preparing registration dossiers, renewals, and amendments with NPRA and foreign authorities, and coordinating certificate applications and regulatory correspondences.

You will help maintain filing systems and support the team in ensuring timely submission and compliance across regulatory activities, with exposure to CPP,

Job description

• Assist in the preparation of documents for new product registration (local and overseas).
• Assist in the renewal and amendment of product licenses with NPRA and overseas regulatory authorities.
• Assist in the application for certificates such as Health Certificate, Certificate of Pharmaceutical Product (CPP), and Halal Certificate.
• Assist to follow up on regulatory correspondences and maintain proper filing of all regulatory documents.
• Assist in coordinating product analysis wit...