Regulatory Affairs Lead for DNDi–MMV Joint Regulatory Platform at Drugs for Neglected Diseases initiative

Geneva, Geneva, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

10 Jul, 26

Salary

0.0

Posted On

11 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory strategy, Strategic leadership, Regulatory affairs, Clinical development, Regulatory submissions, Stakeholder management, Project management, Regulatory intelligence, Global health, Risk assessment, Mentorship, Policy development, Capacity building, Regulatory compliance, Cross-functional leadership

Industry

Research Services

Description

About the Department 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. Overview We are now seeking a senior, visionary Regulatory Sciences Lead to further strengthen strategic regulatory leadership across both organizations’ R&D portfolios. The overall purpose of this role is to provide visionary leadership in regulatory sciences across the joint DNDi–MMV platform, shaping innovative and globally aligned regulatory strategies that accelerate the development, approval, and equitable access to life-saving medicines for populations affected by neglected diseases. Responsibilities 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. Reporting line & Interactions 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. Experience and Education 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. Skills and competencies Advanced expertise in managing high-impact functions, programmes, or complex initiatives. Strong leadership in programme or functional development and delivery, with impact across teams, regions, or strategic areas. Ability to provide expert advice and guidance to senior leaders on specialized topics within their domain. Effective communication and ability to represent their area of responsibility in senior-level discussions. 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. Other requirements 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. We consider individuals for employment based on their skills, abilities and experience. We thrive to attract and hire a strong, talented and diverse workforce, prohibiting discrimination based on race, colour, religious or political beliefs, age, nationality, physical, mental or developmental disability, gender, sexual orientation. What to expect in the recruitment process: Shortlisted candidates can expect a structured recruitment process which includes three phases and is expected to span approximately 8 to 10 weeks from application to employment offer. The process typically includes: 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. Please note that the exact steps, sequencing and timelines may vary depending on the availability of candidates and stakeholders, and may be adjusted as the process progresses. We strongly encourage applications from candidates based outside the Geneva region, including candidates from disease-endemic countries, and welcome applications from people with disabilities. DNDi and MMV are committed to building diverse and inclusive teams and will make reasonable accommodations throughout the recruitment process where needed. For international hires relocating to Geneva, relocation support will be provided. Important note for candidates By applying to this position, you acknowledge that your application and personal data will be shared with both DNDi and MMV as part of the joint recruitment process. The employment contract will be issued by DNDi, while the role itself is embedded within, and will serve, the shared DNDi–MMV Regulatory Sciences Platform across both organizations’ programmatic portfolios. DEI Statement DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.

Responsibilities

Provide visionary leadership in regulatory sciences across the joint DNDi–MMV platform to shape globally aligned strategies for medicine development and approval. Oversee end-to-end regulatory strategies, manage interactions with health authorities, and strengthen regional regulatory capacity in disease-endemic countries.