Head of Regulatory Affairs at DP World

Job Function:

• To lead and oversee Regulatory Affairs, Quality Assurance, and Pharmacovigilance activities across Sub-Saharan African markets for the Integrated Commercial Solutions (ICS) business.
• The role is responsible for ensuring full compliance with applicable Medicines and Pharmacy Acts, health authority regulations, internal SOPs, and GxP (Good Practices).

Key Accountabilities:

Regulatory & Compliance Oversight:

• Ensure Regulatory, Quality, and Pharmacovigilance teams meet statutory requirements under the Pharmacy Act and relevant regulatory guidelines to maintain product licenses.
• Act as the primary liaison with regulatory health authorities, principals, distributors, and affiliates to ensure compliance with GxP standards and registered product requirements.

Pharmacovigilance:

• Ensure timely and compliant reporting of adverse events through oversight of the Qualified Person Responsible for Pharmacovigilance (QPPV).
• Ensure pharmacovigilance systems meet local and international regulatory requirements.

Quality Assurance & QMS:

• Provide oversight of Quality Management Systems (QMS), ensuring adherence to SOPs and GxP standards.
• Oversee product release processes, complaints handling, and recall procedures to ensure regulatory compliance.

Leadership & Strategy:

• Lead and structure the Regulatory, Quality, and PV teams to align with organizational goals.
• Develop and implement the company’s regulatory compliance strategy.
• Ensure all regulatory processes are properly documented and aligned with internal SOPs.

Qualifications:

• Bachelor of Pharmacy (BPharm) or Master’s degree in Pharmacy or related field.
• Active license as a practicing pharmacist with the relevant Pharmacy Council.

Skills and Experience:

• Minimum 7–9 years’ experience in Regulatory Affairs, Quality Assurance, and Pharmacovigilance.
• Experience in pharmaceuticals and/or medical devices.
• Prior leadership or team management experience is required.