Remote Global Regulatory Affairs Specialist

Placements24; Richards Bay; Remote; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Fully remote role

Job summary

Placements24 is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist to support global submissions from anywhere. You will navigate international regulatory requirements and work across R&D, Manufacturing, and Marketing to ensure compliance.

This fully remote role emphasizes strategic regulatory planning, timely dossiers (CTD/IND/NDA/MAA), and proactive liaison with health authorities to drive product approvals worldwide.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field required.
• Minimum of 5 years in pharmaceutical regulatory affairs.
• Experience submitting regulatory applications in major markets (US, EU, etc.).

Responsibilities

• Prepare, review, and submit regulatory dossiers to health authorities globally.
• Interpret regulatory guidelines (ICH, FDA, EMA, SAHPRA) to product development.
• Develop regulatory strategies for registration and lifecycle maintenance.
• Liaise with regulatory agencies, respond to queries and manage interactions.
• Monitor regulatory environment changes and assess impact on products.
• Conduct regulatory due diligence for BD activities and acquisitions.
• Review labeling, advertising, and promotional materials for compliance.
• Collaborate with R&D, Clinical, Marketing, and Manufacturing teams.
• Maintain regulatory databases and ensure accuracy of information.

Skills

Regulatory affairs

Regulatory submissions

Analytical skills

Project management

Communication skills

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Tools

Regulatory information management systems

Job description

Placements24 is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist to support global submissions from anywhere. You will navigate international regulatory requirements and work across R&D, Manufacturing, and Marketing to ensure compliance.

This fully remote role emphasizes strategic regulatory planning, timely dossiers (CTD/IND/NDA/MAA), and proactive liaison with health authorities to drive product approvals worldwide.