GM Regulatory Affairs

Job Description

Siza Internationals Pvt. Ltd., a pharmaceutical company based in Lahore, is seeking an experienced Regulatory Affairs Professional to manage regulatory compliance and product lifecycle activities.

Key Responsibilities

• Prepare and manage submissions for new plant licensing and new product registrations.
• Compile, review, and maintain regulatory documentation for new molecule registrations, renewals, and variations.
• Draft clear regulatory correspondence and responses for DRAP queries and inspections.
• Monitor and interpret DRAP regulations and pharmaceutical legislation to ensure company compliance.
• Coordinate with cross-functional teams (QA, Production, R&D) to gather required dossiers and technical information.
• Track submission timelines, follow up on approvals, and maintain accurate records of regulatory activities.

Job Specification

• Must-have: