Senior Regulatory Affairs Specialist – Pharma (Rustenburg, SA)

Placements24; Rustenburg; Hybride; ZAR 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Health insurance

Pension plan

Profit sharing

Generous leave

Training programs

Résumé du poste

Placements24 is seeking an experienced Regulatory Affairs Specialist in Rustenburg to ensure compliance with SAHPRA and international guidelines. You will prepare dossiers, liaise with health authorities, and guide cross-functional teams on regulatory requirements across product lifecycles.

The role requires a life sciences degree and 4+ years in regulatory affairs, with strong analytical and communication skills for interactions with regulators and internal stakeholders.

Qualifications

• Bachelor’s degree in a life science field and 4+ years in pharma regulatory affairs.
• Experience preparing CTD dossiers for regulatory approvals.
• Strong knowledge of SAHPRA and international guidelines.

Responsabilités

• Prepare, review, and submit regulatory submissions to health authorities.
• Maintain regulatory compliance for products throughout their lifecycle.
• Interpret guidelines and assess impact on products and processes.
• Coordinate with R&D, QA, and Marketing to meet regulatory requirements.
• Develop regulatory strategies to support development and commercialization.

Connaissances

Regulatory affairs

Project management

Analytical thinking

Communication

Formation

Bachelor's degree in life sciences

Description du poste

Placements24 is seeking an experienced Regulatory Affairs Specialist in Rustenburg to ensure compliance with SAHPRA and international guidelines. You will prepare dossiers, liaise with health authorities, and guide cross-functional teams on regulatory requirements across product lifecycles.

The role requires a life sciences degree and 4+ years in regulatory affairs, with strong analytical and communication skills for interactions with regulators and internal stakeholders.