Regulatory Specialist

Key Duties & Responsibilities

Execute new product registration including preparing, reviewing of registration dossiers in accordance with regulatory requirements.

Pharmacist with Hands on Experience of Regulatory Guidelines as per Ministry of Health of Malaysia

Expereince of dossier comilation and submission to health authorities.

Respond to additional requests, queries from health authority until approval.

Comply with regulatory requirements to maintain validity of existing licenses (exaple- Product license, manufacturing license, import license) through timely submissions and renewals.

Attention to details and Ensure compliance with quality procedures stipulated for quality affairs.

Support any audits, inspections, and plan/ suggest improvements to operations.

Handle any other assigments as advised by supervisor.