DNDi is looking for a Regulatory Affairs Lead for DNDi–MMV Joint Regulatory Platform

Position: Regulatory Affairs Lead for DNDi–MMV Joint Regulatory Platform

Job ID: 1236

Location: Geneva, Switzerland (Hybrid)

Contract Type: Full-time

Purpose of the position

The DNDi–MMV Joint Regulatory Platform (JRP) is a collaboration between the Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV), two product development partnerships (PDPs) that share a common mission to develop innovative, affordable, and accessible treatments for neglected diseases.

The Regulatory Affairs Lead will be responsible for overseeing the regulatory strategy and execution of the JRP. This role will ensure the successful registration of development projects across multiple countries in endemic regions. The incumbent will work closely with internal teams at both DNDi and MMV, as well as with external stakeholders including regulatory agencies, partners, and donors.

Key responsibilities

• Develop and implement robust regulatory strategies for R&D projects within the joint portfolio.
• Coordinate interactions with regulatory authorities (e.g., FDA, EMA, WHO, and National Regulatory Authorities in endemic countries).
• Oversee the preparation and submission of regulatory dossiers (including CTAs, NDAs, and MAAs).
• Provide regulatory guidance and support to project teams to ensure compliance with international standards and local requirements.
• Maintain up-to-date knowledge of the global regulatory landscape, particularly concerning neglected diseases.
• Manage and mentor a small team of regulatory professionals.
• Participate in relevant industry working groups and advocacy activities.

Minimum requirements

• Advanced degree in Pharmacy, Life Sciences, or related field (PhD or PharmD preferred).
• Minimum of 10-12 years of experience in Regulatory Affairs, including significant experience in the pharmaceutical or biotech industry.
• Strong knowledge of global drug development and registration pathways.
• Proven experience in leading regulatory submissions for new drug products, ideally in both developed and emerging markets.
• Experience in infectious diseases or neglected tropical diseases (NTDs) would be a strong asset.
• Excellent communication and negotiation skills, with the ability to build consensus among diverse stakeholders.
• Fluency in English (written and spoken) is required; knowledge of French or other languages is an asset.

Other specifications

• This position is based in Geneva, Switzerland.
• DNDi offers a competitive package and a mission-driven work environment.
• Ability to travel internationally as required.

How to apply

To apply, please visit the online application portal. Please submit a cover letter and your CV.

Only shortlisted candidates will be contacted.

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