Regulatory Affairs Specialist

Job Overview

Location: Petaling Jaya, Selangor

Responsibilities

• Prepares, compiles, and submits regulatory dossiers for new product registrations, renewals, and post-approval variations.
• Ensures timely maintenance of product licenses by managing labeling revisions and CMC (Chemistry, Manufacturing, and Controls) updates.
• Handles and responds to queries from regulatory authorities, while monitoring and tracking submission status to ensure compliance timelines are met.
• Collaborates closely with cross‑functional teams to ensure alignment and consistency across regulatory, quality, and commercial activities.
• Stays up to date with local and international regulatory requirements to ensure the company remains compliant.
• Supports audits and inspections by maintaining accurate, well‑organized, and up‑to‑date regulatory documentation.
• Provides support in additional regulatory projects and ...