Remote Regulatory Affairs Specialist – Pharma Compliance

Placements24; Durban; Hybrid; ZAR 900.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Health insurance

Remote work flexibility

Professional development

Zusammenfassung

Placements24 seeks a Regulatory Affairs Specialist to join our Durban-based team. You will navigate SAHPRA and global regulations, prepare and submit dossiers, and provide strategic regulatory guidance to support product development and lifecycle management.

The role offers fully remote work flexibility, with opportunities to influence regulatory strategy across multiple markets and ensure timely approvals for essential medicines.

Qualifikationen

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field
• 4+ years in regulatory affairs within pharma
• Knowledge of SAHPRA and international regs (EMA, FDA) is desirable
• Experience preparing regulatory dossiers (CTD)
• Strong understanding of drug development and manufacturing
• Excellent written and verbal communication, detail-oriented
• Ability to manage multiple projects and meet deadlines
• Proficiency in regulatory information systems

Aufgaben

• Prepare, review, and submit regulatory dossiers for NDAs and variations in SA and target markets
• Interpret regulatory requirements and keep internal stakeholders informed
• Liaise with regulatory agencies, respond to queries, facilitate approvals
• Develop and implement regulatory strategies to support development and lifecycle management
• Ensure compliance with SAHPRA and international health authority regulations
• Maintain regulatory databases and records of submissions and approvals
• Review and approve promotional materials and labeling for compliance
• Participate in cross-functional meetings to provide regulatory input
• Monitor regulatory changes and assess impact on products and operations

Kenntnisse

Regulatory affairs

Dossier submission

Regulatory strategy

Stakeholder communication

Project management

Ausbildung

Bachelor's/Master's degree in Pharmacy/chemistry/biology

Jobbeschreibung

Placements24 seeks a Regulatory Affairs Specialist to join our Durban-based team. You will navigate SAHPRA and global regulations, prepare and submit dossiers, and provide strategic regulatory guidance to support product development and lifecycle management.

The role offers fully remote work flexibility, with opportunities to influence regulatory strategy across multiple markets and ensure timely approvals for essential medicines.