Senior Global Regulatory Affairs Lead — Dossier Strategy

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

Benefits offered by this job

Health benefits

Career advancement

Team environment

Learning opportunities

Job summary

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory submissions and strategy from Benoni, Gauteng. You will coordinate with health authorities worldwide and guide product lifecycle decisions to ensure market access and compliance.

The role requires extensive experience in regulatory affairs, CTD dossier preparation, and strong cross-functional collaboration to support development and post-approval activities.

Qualifications

• 6+ years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SAHPRA and global submission requirements.
• Experience preparing and managing CTD dossiers.
• Strong understanding of product development, manufacturing and QA.
• Excellent communication and negotiation skills.
• Proficiency with regulatory information management systems desirable.
• Detail-oriented with strong organizational skills.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for NDAs, variations, and renewals (SAHPRA, FDA, EMA).
• Act as primary contact with regulatory health authorities and manage inquiries.
• Interpret and advise on national and international regulatory requirements and guidelines.
• Review labeling, promotional materials, and product information for compliance.
• Develop regulatory strategies for development and lifecycle management.
• Conduct regulatory intelligence to stay ahead of changes.
• Oversee post-approval activities (annual reports, safety updates).
• Collaborate with R&D, Clinical, Quality, Manufacturing, Marketing to meet lifecycle requirements.
• Participate in regulatory inspections and provide support as needed.
• Maintain regulatory documentation and databases.

Skills

Regulatory strategy

Regulatory intelligence

Stakeholder communication

Prioritization

Analytical thinking

Education

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

Tools

Regulatory information management systems

Job description

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory submissions and strategy from Benoni, Gauteng. You will coordinate with health authorities worldwide and guide product lifecycle decisions to ensure market access and compliance.

The role requires extensive experience in regulatory affairs, CTD dossier preparation, and strong cross-functional collaboration to support development and post-approval activities.