GM Regulatory Affairs

Job details

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