Regulatory Affairs Manager

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 ...