1. Regulatory Strategy & Market Access
Develop and execute regulatory strategies to support recent 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 monitor product registration stat