Senior Regulatory Affairs Lead: Global Submissions

Placements24; Klerksdorp; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Medical & dental coverage

Retirement plan

Generous annual leave

Professional development

Diverse product range

Collaborative culture

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for its operations in Klerksdorp, North West. The role involves preparing regulatory submissions for new drug applications, variations, and renewals across international markets, ensuring compliance with SAHPRA, FDA, EMA, and other authorities.

The ideal candidate has 5–7 years of pharmaceutical regulatory experience, strong communication skills, and a strategic mindset to influence regulatory strategy and market access for diverse

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology or related field.
• 5–7 years of experience in pharmaceutical regulatory affairs.
• Proven experience with CTD, ANDA, NDA submissions.
• Excellent written and verbal English communication skills.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, ANDA, NDA) for new drug applications and variations.
• Interpret and apply guidelines from SAHPRA, FDA, EMA, and MHRA.
• Liaise with regulatory agencies and respond to queries on behalf of the company.
• Provide regulatory guidance to R&D, QA, and Clinical Affairs.
• Develop regulatory strategies to support lifecycle management and market access.
• Monitor regulatory landscape changes and assess impact on products.
• Ensure labeling, promotion, and advertising comply with regulations.
• Manage post-approval commitments and timely updates.
• Conduct regulatory intelligence and provide strategic insights to project teams.
• Maintain up-to-date regulatory documentation and databases.

Skills

Regulatory affairs

Communication skills

Analytical skills

Problem-solving

Team collaboration

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Biology or related field

Tools

Regulatory submission software

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist for its operations in Klerksdorp, North West. The role involves preparing regulatory submissions for new drug applications, variations, and renewals across international markets, ensuring compliance with SAHPRA, FDA, EMA, and other authorities.

The ideal candidate has 5–7 years of pharmaceutical regulatory experience, strong communication skills, and a strategic mindset to influence regulatory strategy and market access for diverse