Senior Regulatory Affairs Manager – SAHPRA Expert

Placements24; Vereeniging; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Medical aid

Disability insurance

Retirement savings

Relocation assistance

Professional development

Job summary

Placements24 is seeking a strategic Regulatory Affairs Manager in Vereeniging to lead regulatory submissions, ensure SAHPRA compliance, and guide a team across a diverse product portfolio. The role focuses on market access, lifecycle management, and proactive regulatory planning.

The ideal candidate has 7+ years in pharmaceutical regulatory affairs, deep SAHPRA knowledge, and strong leadership to drive compliance and timely approvals.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• 7+ years of progressive experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA regulations and submission requirements for pharmaceuticals.
• Proven experience in preparing and submitting successful marketing authorization applications.
• Excellent analytical, problem-solving, and strategic thinking skills.
• Strong leadership and team management capabilities for a Vereeniging-based team.

Responsibilities

• Develop and implement regulatory strategies for product registration, lifecycle management, and variations in target markets.
• Prepare, review, and submit regulatory dossiers to SAHPRA and other health authorities in compliance with applicable guidelines.
• Liaise effectively with regulatory agencies, responding to queries and ensuring timely approvals.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Oversee the labeling and promotional material review processes to ensure regulatory compliance.
• Manage and mentor a team of regulatory affairs professionals, fostering their growth and development.

Skills

Regulatory strategy

Dossier preparation

Leadership

Project management

Education

Bachelor's or Master's degree in Pharmacy/ Chemistry/ Life Sciences

Job description

Placements24 is seeking a strategic Regulatory Affairs Manager in Vereeniging to lead regulatory submissions, ensure SAHPRA compliance, and guide a team across a diverse product portfolio. The role focuses on market access, lifecycle management, and proactive regulatory planning.

The ideal candidate has 7+ years in pharmaceutical regulatory affairs, deep SAHPRA knowledge, and strong leadership to drive compliance and timely approvals.