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.
