Associate Director, Regulatory Affairs

MSD Malaysia; Midrand; Hybrid; ZAR 2,000,000 - 3,200,000; Full time

Job summary

MSD Malaysia in Hybrid Midrand is seeking a senior Regulatory Affairs leader to direct regulatory strategy and team performance. You will shape submissions, ensure timely approvals, and guide cross-functional programs for market access.

You will lead regulatory submissions, lifecycle management, and provide strategic guidance across development, launches, and compliance, while building key health authority relationships and mentoring the team.

Qualifications

• Must hold a Pharmacy degree and be registered.
• Minimum 6 years in Regulatory Affairs with SAHPRA exposure.
• Experience leading teams and cross-functional collaboration.

Responsibilities

• Lead and develop Regulatory Affairs team with clear direction.
• Develop and execute regulatory strategies for timely approvals.
• Ensure submissions, approvals, and lifecycle management of marketing authorisations.
• Provide strategic regulatory guidance to support development, launches and access.
• Maintain compliance with local regulations and company policies.
• Monitor regulatory intelligence and emerging trends.
• Build relationships with health authorities and external stakeholders.
• Represent Regulatory Affairs in inspections and audits.
• Support trials, safety reporting, labeling, and promotions review.
• Drive policy engagement and advocacy to shape external environment.
• Collaborate with regional/global/local stakeholders to accelerate access.
• Ensure effective regulatory systems, budgets, and training.
• Coach and develop talent; maintain therapeutic area expertise.

Skills

Regulatory leadership

Regulatory strategy

People management

Stakeholder engagement

Regulatory submissions

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.

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

Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 10/5/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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.