Regulatory Affairs Manager

About the role

Siza Internationals Pvt. Ltd., a leading pharmaceutical company in Lahore, is looking for a seasoned Regulatory Affairs professional to lead compliance and product lifecycle activities. The role involves managing plant licensing, product registrations, and ongoing interactions with the Drug Regulatory Authority of Pakistan (DRAP).

Key responsibilities

• Prepare and submit applications for new plant licensing and product registrations.
• Compile, review, and maintain regulatory dossiers for new molecules, renewals, and variations.
• Draft regulatory correspondence and respond to DRAP queries and inspection findings.
• Monitor DRAP regulations and pharmaceutical legislation to ensure continuous compliance.
• Coordinate with QA, Production, and R&D teams to collect required technical and quality documentation.
• Track submission timelines, follow up on approvals, and keep accurate records of all regulatory activities.

Required profile

• Practical knowledge of DRAP regulations, guidelines, and Pakistani pharmaceutical legislation.
• Proven experience preparing regulatory dossiers for plant licensing and product registration.
• Strong regulatory writing and documentation abilities.
• Experience liaising with regulatory authorities and handling queries, approvals, and renewals.
• Ability to work collaboratively with cross‑functional teams.
• High attention to detail and strong organizational skills.

Required skills

• Knowledge of DRAP regulations and pharmaceutical legislation
• Regulatory dossier preparation
• Regulatory writing and correspondence
• Submission management
• Liaison with regulatory authorities

What we offer

• Incentive bonus