Assistant Manager – Regulatory Affairs (Pharma)

About the role

We are seeking an Assistant Manager for Regulatory Affairs to lead and support our pharmaceutical regulatory activities in Lahore. The successful candidate will manage plant licensing, product registrations and ensure full compliance with Drug Regulatory Authority of Pakistan (DRAP) regulations. This position works closely with internal teams to prepare accurate documentation and respond to regulatory queries.

Key responsibilities

• Prepare and submit applications for new manufacturing plant licences.
• Compile and manage documentation for new product and new molecule registrations.
• Develop regulatory submissions, dossiers and licensing documents.
• Correspond with DRAP, follow up on approvals, renewals and address regulatory queries.
• Monitor regulatory changes and update internal procedures accordingly.
• Coordinate with cross‑functional teams to gather required data and ensure timely submissions.
• Maintain accurate regulatory records and support audits or inspections as needed.

Required profile

• Strong knowledge of DRAP regulations and pharmaceutical legislation.
• Proven experience preparing regulatory submissions and dossiers.
• Excellent written communication and stakeholder coordination skills.
• Detail‑oriented with ability to manage timelines and follow‑ups.

Required skills

• Regulatory writing
• Documentation management

What we offer

• Competitive monthly salary (PKR 60,000 – 120,000).
• Incentive bonus.