Associate Director, Regulatory Affairs

1253 MSD (Proprietary) Limited; 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

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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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