Senior Regulatory Affairs Lead for Africa Strategy

MSD; Midrand; On-site; ZAR 1,000,000 - 1,800,000; Full time

Job summary

MSD in Midrand seeks an accomplished Regulatory Affairs leader to drive strategies, lead a high-performing team, and ensure timely regulatory submissions across SA and Sub-Saharan Africa.

You will collaborate with global and regional teams to accelerate patient access, maintain compliance, and guide product development through lifecycle management. A pharmacy degree and 6+ years in regulatory affairs are essential.

Qualifications

• Bachelor's degree in Pharmacy (required).
• Minimum 6 years' Regulatory Affairs experience with SAHPRA engagement.
• Experience across Sub-Saharan Africa advantageous.
• Strong knowledge of South African pharmaceutical legislation and guidelines.
• 3+ years' experience in people leadership and team management.

Responsibilities

• Lead and develop the Regulatory Affairs team with clear direction and people management.
• Develop and execute regulatory strategies for timely approvals and product positioning.
• Ensure timely submission, approvals, and lifecycle management of marketing authorisations.
• Provide strategic regulatory guidance to support development, launches and market access.
• Maintain compliance with local regulatory requirements and quality standards.
• Monitor regulatory intelligence and emerging regulatory trends.
• Build relationships with health authorities and external stakeholders.
• Represent Regulatory Affairs in inspections, audits, and cross-functional initiatives.
• Support clinical trials, safety reporting, labeling, and promotional review.
• Drive regulatory policy engagement to shape external environment.
• Collaborate with regional/global/local stakeholders to accelerate patient access.
• Ensure implementation of regulatory systems, databases, and training.
• Manages, coaches, and develops talent.
• Maintain scientific knowledge for therapeutic areas.

Skills

Adaptability

Cross-Functional Teamwork

Data Management

People Management

Pharmacovigilance

Policy Implementation

Regulatory Compliance

Regulatory Operations

Regulatory Policies

Regulatory Submissions

Strategic Thinking

Teamwork

Education

Bachelor's degree in Pharmacy

Job description

MSD in Midrand seeks an accomplished Regulatory Affairs leader to drive strategies, lead a high-performing team, and ensure timely regulatory submissions across SA and Sub-Saharan Africa.

You will collaborate with global and regional teams to accelerate patient access, maintain compliance, and guide product development through lifecycle management. A pharmacy degree and 6+ years in regulatory affairs are essential.