Regulatory Affairs Lead for DNDi–MMV Joint Regulatory Platform

• 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

• 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.

• Job title reports to Director of Regulatory Sciences at DNDi
• 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.

• 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.

• Phase 1: initial screening interviews to explore motivation, experience and overall fit with the role and the joint DNDi–MMV platform
• Phase 2: in-depth interview with DNDi’s Director for Regulatory Sciences focusing on regulatory expertise, leadership experience and skills
• Phase 3: a technical case-based presentation and discussion, and several in-person meetings and company visits at DNDi and MMV for shortlisted finalists.

Drugs for Neglected Diseases initiative