Global Pharma Regulatory Affairs Specialist

Placements24; Benoni; Hybride; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement contributions

Performance-based incentives

Training and conference attendance

Résumé du poste

Placements24 is seeking a Regulatory Affairs Specialist for our Benoni, Gauteng team. You will ensure compliance of pharmaceutical products with SAHPRA and international requirements, prepare regulatory submissions, liaise with health authorities, and support cross-functional teams.

You will monitor evolving regulations, review labeling and promotional materials, and contribute to regulatory strategies for product lifecycle management.

Qualifications

• Bachelor's degree in a life sciences or legal field is required.
• 4+ years of regulatory affairs experience in pharma.
• Strong knowledge of SAHPRA and international guidelines (FDA/EMA/ICH).
• Experience in preparing regulatory submissions and labeling reviews.

Responsabilités

• Prepare regulatory dossiers (e.g., CTD) for registrations and variations.
• Liaise with SAHPRA, FDA, EMA and others as required.
• Review labeling, promotional materials for compliance.
• Monitor regulatory changes and assess impact on products and operations.
• Manage post-approval activities like annual reports and amendments.
• Provide regulatory guidance to cross-functional teams (R&D, manufacturing, marketing).
• Maintain regulatory databases and filing systems.
• Participate in inspections and audits.
• Contribute to regulatory strategies for product lifecycle management.

Connaissances

Regulatory knowledge

Attention to detail

Project management

Communication skills

Formation

Bachelor's degree in Pharmacy, Chemistry, Biology, or Law

Outils

MS Office Suite

Regulatory information management systems

Description du poste

Placements24 is seeking a Regulatory Affairs Specialist for our Benoni, Gauteng team. You will ensure compliance of pharmaceutical products with SAHPRA and international requirements, prepare regulatory submissions, liaise with health authorities, and support cross-functional teams.

You will monitor evolving regulations, review labeling and promotional materials, and contribute to regulatory strategies for product lifecycle management.