Remote Global Regulatory Manager – Submissions & Strategy

Placements24; Centurion; Hybride; ZAR 1 200 000 - 2 000 000; Plein temps

Avantages offerts par ce poste

Health & wellness programs

Retirement planning options

Performance-driven incentives

Training & conferences

Global project exposure

Résumé du poste

Placements24 seeks a Pharmaceutical Regulatory Affairs Manager for a fully remote role leading regulatory strategy and global submissions. You will guide cross-functional teams across R&D, manufacturing, and commercial to ensure compliant submissions and timely product access.

The ideal candidate holds an advanced degree and 8+ years of regulatory experience, with deep knowledge of SAHPRA, FDA, and EMA processes, and a proven track record in strategic regulatory planning and lifecycle management.

Qualifications

• Advanced degree in Pharmacy, Chemistry, Biology, or related science.
• 8+ years in pharmaceutical regulatory affairs with global submissions track record.
• Deep understanding of SAHPRA, US FDA, EMA regulatory requirements.
• Experience developing and executing regulatory strategies for NME and existing products.
• Strong analytical, problem-solving, and communication skills.

Responsabilités

• Develop and implement global regulatory strategies for NDAs/MAAs and variations.
• Prepare, review, and submit high-quality regulatory dossiers to SAHPRA, FDA, EMA, and others.
• Provide regulatory guidance to R&D, clinical, manufacturing, and commercial teams.
• Monitor evolving regulatory landscapes and advise strategically.
• Manage lifecycle regulatory activities: post-approval changes, annual reports, safety updates.
• Lead regulatory interactions with health authorities (pre-submission meetings, deficiency letters).
• Ensure regulatory compliance throughout product lifecycle and policies.
• Oversee labeling and promotional materials for compliance.

Connaissances

Regulatory strategy

Global submissions

Cross-functional leadership

Regulatory guidance

Drug development

Formation

Masters or PhD in Pharmaceutical Science

Outils

Regulatory databases

Submission software

Description du poste

Placements24 seeks a Pharmaceutical Regulatory Affairs Manager for a fully remote role leading regulatory strategy and global submissions. You will guide cross-functional teams across R&D, manufacturing, and commercial to ensure compliant submissions and timely product access.

The ideal candidate holds an advanced degree and 8+ years of regulatory experience, with deep knowledge of SAHPRA, FDA, and EMA processes, and a proven track record in strategic regulatory planning and lifecycle management.