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Regional Regulatory Affairs Officer

Cospharm Pharmaceuticals

Job Description

Duties & Responsibilities

• Dossier Management & Submissions: Compilation and continuous filing of new dossiers in concerned territories. Ensure all submissions meet specific national regulatory requirements.
• Product registration & Lifecycle Maintenance. Extract registrations of filed products through response submission to NRAs. Also manage post-registration amendments where required and necessary.
• Actively engage with suppliers to ensure all responses to regulatory queries are submitted accurately and on time.
• Data management: Maintain an up-to-date regional dossier database covering concerned territories.
• Pharmacovigilance (PV) & Compliance System: assist and ensure a robust system for pharmacovigilance.
• Collaborate with Business Development and Operations based on organizational needs and business direction.
• Stakeholder Relations: Build and maintain professional relationships with National Regulatory Authorities (NRAs),

Skills/Tags

Qualifications & Experience

• 1st degree in Pharmacy or Life Science.
• At least 2-3 years working in pharmaceutical regulatory industry.
• Experience in regional/multi-country RA industry is an added advantage
• Understanding the intersection of Regulatory affairs, Pharmacovigilance and product lifecycle management.
• Be knowledgeable of the regulatory requirements across SADC and other African countries.

How to Apply?