Senior Regulatory Strategy Lead - Global Pharma (Hybrid)

Placements24; Sandton; Hybrid; ZAR 1,400,000 - 2,300,000; Full time

Benefits offered by this job

Bonus

Long‑term incentives

Health benefits

Retirement plan

Career growth

Job summary

Placements24 seeks a Lead Regulatory Affairs Specialist to join our team in Sandton in a hybrid capacity. You will drive regulatory strategies for new and existing pharmaceutical products, ensuring compliance with FDA, EMA, SAHPRA and ICH guidelines.

A proactive, senior professional will lead cross-functional teams and manage lifecycle activities. The role requires extensive experience navigating complex regulatory pathways, preparing submission dossiers, and guiding post-approval activities.

Qualifications

• Master's or PhD in Pharmacy, Life Sciences, Chemistry, or related field.
• Excellent written and verbal communication; strong leadership and cross-functional collaboration.
• Strategic thinking and decision-making with regulatory expertise.

Responsibilities

• Develop and execute global regulatory strategies for product development, registration, and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD, IND, NDA, MAA) to health authorities worldwide.
• Lead submissions and interactions with regulators during inspections.
• Monitor evolving guidelines and advise on strategic regulatory implications.
• Manage post-approval activities, including variations, renewals, and annual reports.
• Mentor junior staff and collaborate with R&D, Clinical, Manufacturing, Marketing.

Job description

Placements24 seeks a Lead Regulatory Affairs Specialist to join our team in Sandton in a hybrid capacity. You will drive regulatory strategies for new and existing pharmaceutical products, ensuring compliance with FDA, EMA, SAHPRA and ICH guidelines.

A proactive, senior professional will lead cross-functional teams and manage lifecycle activities. The role requires extensive experience navigating complex regulatory pathways, preparing submission dossiers, and guiding post-approval activities.