1. Regulatory Strategy & Market Access
- Develop and execute regulatory strategies to support current product registrations, portfolio expansion, and lifecycle management across Rest of Africa markets.
- Provide regulatory intelligence and proactively assess the impact of evolving regulations on business and product pipelines.
- Partner with commercial, medical, supply chain, and RA/PV quality teams to ensure regulatory alignment with business priorities and market entry plans.
- Identify regulatory risks and opportunities, proposing mitigation strategies to support business growth.
2. Submission & Dossier Lifecycle Management
- Provide strategic oversight for end-to-end dossier lifecycle management, including new registrations, variations, renewals, transfers, amendments, and product maintenance activities.
- Monitor
regulatory submissions
closely
to ensure compliance with country-specific requirements and global regulatory standards.
- To ensure timely completion of cross functional activities
for timely submission of dossiers to achieve business launch timelines and regulatory commitments.
- Drive optimization of dossier management processes across the region.
3. Regulatory Approval & Health Authority Engagement
- Lead interactions with health authorities, regulatory agencies, local partners, and distributors across Rest of Africa markets
for product and plant GMP approvals.
- Oversee regulatory query management and ensure timely, high-quality responses to authority requests.
- Monitor approval timelines, identify bottlenecks, and implement corrective actions to accelerate product approvals.
- Build and maintain effective relationships with external regulatory stakeholders to facilitate business objectives.
4. Portfolio Compliance & Lifecycle Governance
- Ensure continuous compliance of the registered product portfolio through timely execution of variations, renewals and other post-approval commitments.
- Establish governance mechanisms to mo