Regulatory Sciences Senior Manager for DNDi–MMV Joint Regulatory Platform, full-time (or 80

The Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV), two successful mission-driven non-for-profit Product Development Partnership organizations (PDP), have joined forces to create an innovative, shared regulatory sciences platform. This unique collaboration leverages DNDi's broad experience in developing and registering medicines for neglected diseases with MMV's deep malaria-specific expertise to speed up the delivery of effective, affordable and lifesaving medicines for people who need them most.

The shared regulatory science platform is led by DNDi's Director of Regulatory Sciences, with MMV's Chief Medical Officer/Director Clinical Development serving as the anchor point on MMV's side.

We are now seeking a senior, visionary Regulatory Sciences Manager with global experience to further support the strategic regulatory leadership across both organizations' R&D portfolios. Reporting to the Director of Regulatory Sciences at DNDi, this role will be deeply embedded across the joint DNDi-MMV regulatory sciences platform, alongside existing regulatory expertise in both organizations. In this role, the Regulatory Sciences Senior Manager will provide regulatory expertise and functional management across all stages of product development, from early development through registration, lifecycle management, and access, while serving as a shared resource to ensure efficient deployment of specialized regulatory capacity.

The role manages interactions with regulatory authorities such as the European Medicines Agency, US Food and Drug Administration, Swiss medic, and Therapeutic Goods Administration of Australia, as well as WHO, national regulators in endemic countries and regional/continental authorities including the African Medicines Agency (AMA), to secure clear, predictable pathways to approval and access. The role also contributes to regulatory policy, capacity strengthening, and advocacy, ensuring that the priorities of patients in low and middle-income countries are fully represented in global regulatory approaches.

As the Regulatory Sciences Senior Manager, the job holder will:

• Provide management for regulatory sciences across the joint DNDi-MMV platform, ensuring aligned global strategies for development, approval, post-approval evidence generation, and patient access.
• Develop and oversee global regulatory strategies, including end-to-end regulatory strategies, and risk assessments for priority products, integrating target product profiles, clinical and non-clinical development plans, and access considerations to support timely and optimal regulatory outcomes.
• Provide senior management support to help lead and oversee preparation for interactions with regulatory authorities, including early-stage scientific advice meetings, pre-submission consultations, and end-of-Phase II discussions, and ensure high-quality, timely regulatory submissions and responses in collaboration with project teams and partners.
• When DNDi or MMV acts as sponsor, guide and monitor the preparation, submission, and maintenance of regulatory documentation; when external pharmaceutical partners are sponsors, provide strategic oversight to ensure alignment with agreed development plans and access objectives.
• Provide expert regulatory guidance on key development documents such as clinical study protocols, protocol amendments, Investigator's Brochures, IMPDs, CTAs, and non-clinical study plans, ensuring consistency with global regulatory requirements.
• Offer Senior Management level contribution to regulatory intelligence by monitoring global trends, evolving guidelines, and emerging technologies, and translate insights into strategic advice, policy recommendations, and advocacy initiatives; represent the platform at scientific conferences, global health forums, and regulatory stakeholder meetings.
• Strengthen regional regulatory capacity by collaborating with national regulatory authorities in disease-endemic countries, WHO, and regional bodies, and by contributing to training and targeted capacity strengthening initiatives.
• Promote excellence in regulatory sciences by developing and maintaining…