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 include:

• 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: Practical knowledge of DRAP regulations, guidelines, and pharmaceutical legislation in Pakistan.
• Must-have: Proven experience preparing regulatory dossiers for new plant licensing and product registration.
• Must-have: Strong regulatory writing, documentation, and submission skills.
• Must-have: Experience liaising with regulatory authorities and managing queries, approvals, and renewals.
• Must-have: Ability to coordinate with internal teams (QA, Production, R&D) to collect technical and quality documentation.
• Must-have: Attention to detail, organization, and ability to manage multiple regulatory submissions and timelines.

Job Rewards and Benefits: Incentive Bonus