Regulatory Affairs Lead for DNDi–MMV Joint Regulatory Platform
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 Lead to further strengthen 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 Leader will provide regulatory expertise and functional leadership 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 leads interactions with regulatory authorities such as the European Medicines Agency, US Food and Drug Administration, Swissmedic, 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 Leader, the job holder will:
* Provide strategic leadership 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.
* Lead or 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.
* Lead and contribute 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 standard operating procedures, processes, and guidance; delivering training, and ensuring consistent application of regulatory standards and adherence to internal quality systems.
* Provide leadership, mentorship, and matrix management to regulatory staff, consultants, and trainees; foster effective communication and knowledge sharing across teams; and maintain a strong regulatory knowledge management base.
* Contribute senior regulatory expertise to governance bodies, including project teams and scientific and protocol review committees, and support regulatory input for donor reporting and platform level reporting.
* Travel internationally up to 25%, as needed
Why this role is unique:
* A first-of-its-kind joint regulatory platform between two global research and development PDPs, setting a leading-by-example model for non-for-profit collaboration
* The ability to shape the end-to-end regulatory strategy, including filing strategies and licensure, for multiple disease areas and product types.
* A role with both strategic influence and hands-on impact.
* An opportunity to contribute to delivering essential treatments to populations in disease-endemic countries.
* A highly collaborative environment bridging public health, science, and policy.
* Opportunity to shape innovative, accelerated development and approval strategies within the scientific and regulatory environment to enable early access to priority medicines.
We seek a strategic, hands-on regulatory leader with:
* Advanced post-graduate degree in life sciences, pharmacy or medicine or graduate degree with equivalent in experience
* 10+ years in senior-level regulatory roles with global regulatory outcomes, either in pharma, biotech or global health R&D organizations
* Strong track record of successful interactions and submissions to stringent authorities (e.g. FDA, EMA, Swissmedic), and experience with WHO prequalification and regulatory systems in Asia, Latin America and Africa.
* Demonstrated ability to lead high-impact, complex, multinational regulatory programs and work hands-on with strong initiative, structured judgement and problem-solving skills
* Expertise in neglected diseases, malaria, paediatric development, combinations, or infectious diseases in general is highly desirable.
* Outstanding leadership, communication, teamwork and stakeholder management skills.
* Commitment to global health, equity, and mission-driven science, enjoying an international and global health environment.
HOW TO APPLY:
Interested applicants should submit their CV and a cover letter outlining their motivation for the position by 8 May 2026 by applying through the job opening on DNDi's career website - https://careers-dndi.icims.com/jobs/1236/regulatory-affairs-lead-for-dndi%e2%80%93mmv-joint-regulatory-platform/job