GM Regulatory Affairs

Siza Internationals Pvt. Ltd.; Lahore; On-site; PKR 1,200,000 - 2,400,000; Full time

Benefits offered by this job

Incentive Bonus

Job summary

Siza Internationals Pvt. Ltd. in Lahore seeks an experienced Regulatory Affairs Professional to manage regulatory compliance and product lifecycle activities.

You will prepare submissions for plant licensing, registrations, and variations, draft DRAP responses, and ensure ongoing compliance by coordinating with QA, Production, and R&D. This role offers growth within a pharmaceutical-focused environment.

Qualifications

• Must have practical knowledge of DRAP regulations, guidelines, and pharmaceutical legislation in Pakistan.
• Must have proven experience preparing regulatory dossiers for 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.
• Ability to coordinate with internal teams (QA, Production, R&D) to collect technical and quality documentation.
• Attention to detail, organization, and ability to manage multiple regulatory submissions and timelines.

Responsibilities

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

Skills

Regulatory writing

Documentation

Submission management

Job description

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: 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