Regulatory Affairs Lead for DNDi–MMV Joint Regulatory Platform

• About the Department
• Research and Development Department (R&D)
• About the Office
• Location and contract

This function can either be situated in Geneva, under Swiss employment contract and with a hybrid working requirement of 3 days per week on site at DNDI offices.

Alternatively, the successful candidate could be located in Africa or in the EU, under a home-based working set up and with a local contract in the absence of a local DNDI office

Overview

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, 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.

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 medicine

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, Management 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

Responsibilities

• 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 standard operating procedures, processes, and guidance; delivering training and ensuring consistent application of regulatory standards and adherence to internal quality systems.
• Provide 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.
• Reporting line & Interactions
• Job title reports to the Director, Regulatory Sciences
• Works with Regulatory Sciences team in the Research & Develpment department
• This role promotes programs and maintains productive relationships by projecting the image of a credible partner and ensures commitment of partners .

Experience and Education

• 10+ years in senior-level regulatory roles with global regulatory outcomes, either in pharma, biotech or global health R&D organizations
• Demonstrated ability to Manage high-impact, complex, multinational regulatory programs and work hands‑on with strong initiative, structured judgement and problem-solving skills
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in public and private sector is highly desirable
• Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level

Skills and competencies

• Advanced post-graduate degree in life sciences, pharmacy or medicine or graduate degree with equivalent in experience
• 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.

• Expertise in neglected diseases, malaria, paediatric development, combinations, or infectious diseases in general is highly desirable.
• Outstanding management, communication, teamwork and stakeholder management skills.
• Commitment to global health, equity, and mission-driven science, enjoying an international and global health environment.
• Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Very clear and systematic thinking that demonstrates strong judgment and problem solving competencies
• Very strong communication skills in multicultural, multi-lingual environments
• Very strong ability to work effectively as part of a multicultural team
• Very well organized and structured
• Very strong analytical skills
• Very strong ability to lead project delivery
• Very strong ability to manage large size projects with budget management
• Strong strategic thinking and leadership abilities
• Very strong management, negotiation, and advocacy skills
• Very strong ability to exercise high degree of independence to support program delivery and explore new areas of activities
• Very strong ability to interact with internal and external stakeholders
• Lead and motivate a team for optimum performance, supervising junior staff
• Other requirements
• Fluency in English
• Very good knowledge of Microsoft Suite
• Travel internationally up to 25%, as needed
• Full-time (or 80%+), Local employment contract
• 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.

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