Superintendent Pharmacist – Regulatory & Quality Lead

About the role

The Superintendent Pharmacist will provide statutory oversight and strategic accountability for all pharmaceutical operations, ensuring compliance with the Pharmacy and Poisons Act and related regulations. This senior position serves as the primary liaison with regulatory authorities and guarantees uninterrupted market access for the company’s product portfolio.

Key responsibilities

• Lead regulatory compliance as the appointed Superintendent Pharmacist, overseeing product registrations, re‑registrations, variations, and GMP applications.
• Manage import and export permit processes in coordination with PPB, ACA, NBA, NEMA, KEBS and other agencies.
• Advise the Board and Executive Management on pharmaceutical legislation and statutory obligations.
• Establish and maintain a robust Quality Management System (QMS) covering SOPs, CAPA, deviation handling, and non‑conformance processes.
• Oversee product quality reviews, complaint investigations, trend analysis and continuous improvement initiatives.
• Ensure proper receipt, storage, handling, distribution, recall, quarantine and destruction of pharmaceutical products in line with Good Distribution Practice (GDP) and DP World SOPs.

Required profile

• Registered pharmacist with extensive experience in regulatory affairs and pharmaceutical quality management.
• Deep knowledge of Pharmacy and Poisons Act, PPB regulations, GDP, GRP and GvP requirements.
• Proven ability to interact with multiple government agencies and manage complex regulatory submissions.
• Strong analytical mindset with experience in product quality investigations and corrective actions.

Required skills

• Good Distribution Practice (GDP)
• Good Regulatory Practice (GRP)
• Good Vigilance Practice (GvP)
• Quality Management Systems (QMS)
• Standard Operating Procedures (SOP) development
• CAPA and deviation management
• Regulatory submission preparation
• Product registration and GMP application processes