Remote Pharma Regulatory Affairs Manager | Submissions

Placements24; South Africa; Remote; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive salary

Fully remote work

Health insurance

Paid leave

Professional development

Job summary

Placements24 is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Manager to lead regulatory strategies from anywhere in the country. You will manage submissions (CTD, ANDA, NDA) and ensure compliance across global markets, driving lifecycle management and successful market entries.

With 7+ years in regulatory affairs and strong knowledge of FDA/EMA/SAHPRA guidelines, you will coordinate cross-functional teams remotely and communicate effectively with regulatory agencies

Qualifications

• Master's or PhD in a relevant scientific discipline
• 7+ years of pharma regulatory affairs experience
• In-depth knowledge of international guidelines (FDA/EMA/SAHPRA) and dossier formats
• Proven ability to lead remote, cross-functional projects
• Excellent communication, negotiation and strategic thinking skills

Responsibilities

• Develop and implement regulatory strategies for new product registrations and lifecycle management
• Prepare, review, and submit regulatory dossiers to health authorities worldwide
• Serve as primary point of contact with regulatory agencies
• Monitor regulatory changes and assess their impact on the portfolio
• Ensure ongoing compliance with post-approval commitments and regulatory requirements
• Collaborate with R&D, manufacturing, and commercial teams to align activities with business goals

Skills

Regulatory strategy

Regulatory submissions

Stakeholder management

Remote work leadership

Strategic thinking

Communication

Project management

Education

Master's or PhD in a relevant science (Pharmacy, Chemistry, Biology)

Tools

Regulatory information management systems

Job description

Placements24 is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Manager to lead regulatory strategies from anywhere in the country. You will manage submissions (CTD, ANDA, NDA) and ensure compliance across global markets, driving lifecycle management and successful market entries.

With 7+ years in regulatory affairs and strong knowledge of FDA/EMA/SAHPRA guidelines, you will coordinate cross-functional teams remotely and communicate effectively with regulatory agencies