Senior Regulatory Affairs Lead – Strategy & Compliance

MSD Malaysia; Midrand; On-site; 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

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.