Senior Manager – Business Regulatory Affairs (Rest of Africa )

Job description

**Key Responsibilities** **1. Regulatory Strategy & Market Access** - Develop and execute regulatory strategies to support new 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 status, regulatory commitments, and compliance obligations. - Support business continuity through proactive management of regulatory risks impacting product supply and market availability. **5. Regulatory Operations, Systems & Digitalization** - Lead the implementation and continuous improvement of regulatory information management systems and digital tools. - Ensure accuracy, integrity, and real-time visibility of regulatory data, submission trackers, and approval dashboards. - Drive automation initiatives to enhance operational efficiency, productivity, and compliance monitoring. - Develop performance metrics and analytics to support decision-making and resource planning. **6. Stakeholder Management & Business Communication** - Act as the primary regulatory business partner for regional and cross-functional stakeholders. - Provide regular updates to senior leadership on regulatory submissions, approvals, portfolio status, risks, and strategic initiatives. - Represent Regulatory Affairs in business reviews, portfolio discussions, and strategic planning forums. - Drive alignment between regional regulatory objectives and organizational business goals. **Functional/Technical Skills or Industry Experience** - Master's/Bachelor's degree in Pharmacy, Life Sciences, or related discipline. - Techno commercial knowledge for product and plant approvals of Pharmaceutical, Oncology , Biosimilar , Plasma and Hormonal products for Africa region. - 8–10 years of experience in Regulatory Affairs, with significant exposure to Africa markets. - Proven experience in managing product registrations, lifecycle activities, and health authority interactions across multiple African countries. - Strong understanding of regional regulatory frameworks, dossier requirements, and compliance expectations. - Demonstrated leadership experience with team management and stakeholder engagement. - Strong project management, communication, negotiation, and problem-solving skills.