Senior Manager : Inspectorate and Regulatory Compliance

South African Health Products Regulatory Authority; Pretoria; On-site; ZAR 700,000 - 900,000; Full time

Job summary

A national regulatory authority in Pretoria seeks a Senior Manager for Inspectorate and Regulatory Compliance. The ideal candidate will have extensive experience in medicines regulation, strong management skills, and a relevant postgraduate qualification. Responsibilities include developing compliance systems, overseeing regulatory operations, and liaising with stakeholders. This role contributes to public health policies and requires significant regulatory expertise.

Qualifications

• At least 10 years’ experience in medicines regulatory field.
• 5 years at management level supporting business operations.
• Knowledge of GMP, GLP, and GCP.

Responsibilities

• Develop and manage operations of Regulatory Compliance and Inspectorate Programme.
• Contribute to strategic planning with senior management.
• Prepare monthly and annual reports on programme activities.
• Oversee compliance with relevant legislation and inspections.
• Liaise with industry and international regulators.

Skills

Management

Regulatory Compliance

Knowledge of Medicines Act

Education

Pharmacy degree / Registration as a Pharmacist

Post-graduate qualification in Pharmaceutical or Scientific Master’s

Management qualification (MBA / MBL / MAP)

Job description

Job Title: Senior Manager: Inspectorate and Regulatory Compliance

Job Location: Gauteng, Pretoria

Deadline: August 30, 2025

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Requirements:

• Matric certificate, Pharmacy degree / Registration as a Pharmacist with the South African Pharmacy Council (SAPC).
• Post-graduate qualification in Pharmaceutical or Scientific Master’s degree at NQF level 9 as recognised by the South African Qualifications Authority (SAQA).
• Management qualification (MBA / MBL / MAP) or similar qualification will be an added advantage. A valid driver’s license is also required.

Experience:

• At least 10 years’ relevant experience in the medicines regulatory field, of which five (5) years must be at a management level (level 12 – 13) supporting business operations. Two (2) years at senior management level (level 13 – 14) will be an added advantage.
• Extensive knowledge and application of the Medicines & Related Substances Act (Act 101 of 1965) and its Regulations, Hazardous Substances Act 1973, National Health Act 2003, and working knowledge of the Criminal Procedure Act.
• Extensive knowledge of GMP, GLP, GWP, GCP, GVP, and GDP.

Duties:

• Develop and coordinate systems for managing all operations of the Regulatory Compliance and Inspectorate Programme. Develop strategies, annual performance plans, operational plans, and budgets aligned with organisational needs to ensure effective resource utilization.
• Contribute to strategic and operational planning as a member of the senior management team to achieve organisational objectives and meet stakeholder needs.
• Prepare monthly, quarterly, and annual reports on programme activities, including monitoring timelines.
• Oversee enforcement of relevant legislation, including monitoring importation and use of narcotics, handling of medicines, product recalls, investigations of counterfeit medicines, and inspections (GMP, GCP, GWP, GLP, GVP, GDP).
• Oversee preparation and endorsement of reports for relevant advisory committees in accordance with legal requirements and SOPs of SAHPRA.
• Manage communication regarding inspections, compliance, and licensing to guide public health policies and interventions.
• Develop, implement, and maintain regulations, guidelines, policies, and procedures to ensure compliance with international and national standards.
• Liaise with industry representatives, international regulators, law enforcement, and other stakeholders to establish productive relationships.
• Ensure active participation of South African regulatory functions in the global arena.
• Oversee compliance with SLAs with outsourced services like laboratories to meet quality and delivery standards.
• Train and manage subordinate managers, promoting high ethical conduct and performance standards.
• Handle general financial, human resources, and performance management functions.
• Perform additional functions as delegated by the Chief Regulatory Officer or CEO.