Associate Director, Regulatory Affairs

MSD South Africa; Johannesburg; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MSD South Africa seeks a seasoned Regulatory Affairs leader to direct the department, shaping regulatory strategy and ensuring timely approvals for medicines. You will oversee submissions, lifecycle management, and interactions with SAHPRA, while guiding development, launches, and market access initiatives.

The role requires deep regulatory knowledge, strong leadership, and the ability to coordinate with regional and global teams to accelerate patient access to therapies.

Qualifications

• Bachelor’s degree in Pharmacy (required).
• Minimum 6 years’ Regulatory Affairs experience with SAHPRA engagement.
• Experience across Sub-Saharan Africa is advantageous.
• 3+ years in people leadership and team management.

Responsibilities

• Lead and develop Regulatory Affairs team with clear direction and people management.
• Develop and execute regulatory strategies to secure timely approvals and maintain product positioning.
• Ensure submission, approval, and lifecycle management of marketing authorisations (applications, variations, renewals, major indications).
• Provide strategic regulatory guidance to support product development, launches, and market access.
• Maintain compliance with local regulations, policies, and quality standards.
• Monitor regulatory intelligence, legislative changes, and emerging 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, promotional review, and other compliance activities.
• Drive policy engagement to shape the external regulatory environment.
• Collaborate with regional/global/local stakeholders to accelerate patient access to medicines.
• Implement regulatory systems, databases, procedures, and training programs.
• Manage, coach, and develop talent; maintain therapeutic area expertise.

Skills

Regulatory leadership

Stakeholder management

Strategic thinking

Project management

Communication

Education

Bachelor’s degree in Pharmacy

Job description

Job Description

• Lead and develop the Regulatory Affairs team, providing clear direction and people management.
• Develop and execute regulatory strategies to secure timely approvals and maintain optimal product positioning.
• Ensure timely submission, approval, and lifecycle management of marketing authorisations, including new applications, variations, renewals, and major indications.
• Provide strategic regulatory guidance to support product development, launches, business development, and market access initiatives.
• Maintain compliance with local regulatory requirements, company policies, and quality standards.
• Monitor and communicate regulatory intelligence, legislative changes, and emerging regulatory trends.
• Build and maintain effective relationships with health authorities, industry associations, and key external stakeholders.
• Represent Regulatory Affairs in inspections, audits, and cross-functional business initiatives.
• Support clinical trials, safety reporting, labelling, promotional review, and other regulatory compliance activities.
• Drive regulatory policy engagement and advocacy activities to shape the external regulatory environment.
• Collaborate closely with regional, global, and local stakeholders to achieve business objectives and accelerate patient access to medicines.
• Ensure effective implementation of regulatory systems, databases, procedures, and training programme.
• Manages, coaches, and develops talent. Maintain scientific knowledge and expertise for our company's therapeutic areas.
• Establishes a regular system of communication of the department to update information on the status of main activities and mainly to share experiences, discuss strategies and put in common lessons to be learned.
• Administers the departmental budget.

Key Responsibilities

• Lead and develop the Regulatory Affairs team, providing clear direction and people management.
• Develop and execute regulatory strategies to secure timely approvals and maintain optimal product positioning.
• Ensure timely submission, approval, and lifecycle management of marketing authorisations, including new applications, variations, renewals, and major indications.
• Provide strategic regulatory guidance to support product development, launches, business development, and market access initiatives.
• Maintain compliance with local regulatory requirements, company policies, and quality standards.
• Monitor and communicate regulatory intelligence, legislative changes, and emerging regulatory trends.
• Build and maintain effective relationships with health authorities, industry associations, and key external stakeholders.
• Represent Regulatory Affairs in inspections, audits, and cross-functional business initiatives.
• Support clinical trials, safety reporting, labelling, promotional review, and other regulatory compliance activities.
• Drive regulatory policy engagement and advocacy activities to shape the external regulatory environment.
• Collaborate closely with regional, global, and local stakeholders to achieve business objectives and accelerate patient access to medicines.
• Ensure effective implementation of regulatory systems, databases, procedures, and training programme.
• Manages, coaches, and develops talent. Maintain scientific knowledge and expertise for our company's therapeutic areas.
• Establishes a regular system of communication of the department to update information on the status of main activities and mainly to share experiences, discuss strategies and put in common lessons to be learned.
• Administers the departmental budget.

Qualifications & Experience

• Bachelor’s degree in Pharmacy (required).
• Minimum 6 years’ experience in Regulatory Affairs or a related pharmaceutical regulatory function, including direct engagement with regulatory authorities.
• Demonstrated and significant experience working with the South African Health Products Regulatory Authority (SAHPRA) is essential.
• Experience across Sub-Saharan Africa will be advantageous.
• Sound knowledge of South African pharmaceutical legislation, regulations, and regulatory guidelines.
• Minimum 3 years’ experience in people leadership and team management.

Skills & Competencies

• Strong verbal and written communication skills.
• Excellent planning, organisational, and project management capabilities.
• High attention to detail and commitment to quality and compliance.
• Ability to manage multiple priorities and perform effectively under pressure.
• Strong stakeholder management, negotiation, and influencing skills.
• Demonstrated ability to lead, coach, and coordinate teams in a cross-functional environment.
• Strategic thinker with the ability to translate regulatory requirements into business solutions.

Required Skills

Adaptability, Cross-Functional Teamwork, Data Management, People Management, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Operations, Regulatory Policies, Regulatory Submissions, Strategic Thinking, Teamwork

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Job Posting End Date

10/5/2026

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