Remote Global Regulatory Affairs Specialist

Placements24; Benoni; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Fully remote work environment

Competitive salary

Performance-based bonus

Health, dental, and vision insurance

Flexible paid time off

Job summary

Placements24 seeks a Regulatory Affairs Specialist to manage regulatory submissions and global compliance for pharmaceutical products. The role is fully remote, enabling contribution to worldwide health initiatives from home.

You will prepare and submit regulatory documentation, ensuring adherence to evolving guidelines with strong attention to detail and proactive communication. The candidate should have at least 5 years in regulatory affairs, deep knowledge of global requirements, and

Qualifications

• Bachelor's degree in a relevant field.
• Minimum of 5 years in regulatory affairs within pharma.
• Knowledge of global regulatory requirements and submission processes.
• Experience with electronic submission systems (eCTD).
• Strong written and verbal communication; ability to work remotely.

Responsibilities

• Prepare, review, and submit regulatory dossiers for NDAs and variations.
• Ensure compliance with FDA/EMA/SAHPRA guidelines for registration and maintenance.
• Liaise with regulatory agencies and manage submissions.
• Monitor regulatory changes and assess impact on products.
• Maintain regulatory docs and databases; collaborate with R&D, manufacturing, and marketing.

Skills

Regulatory knowledge

Regulatory strategy

Project management

Communication

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Tools

eCTD submission systems

Job description

Placements24 seeks a Regulatory Affairs Specialist to manage regulatory submissions and global compliance for pharmaceutical products. The role is fully remote, enabling contribution to worldwide health initiatives from home.

You will prepare and submit regulatory documentation, ensuring adherence to evolving guidelines with strong attention to detail and proactive communication. The candidate should have at least 5 years in regulatory affairs, deep knowledge of global requirements, and