Medicines for Malaria Venture (MMV) is the world’s leading product development partnership (PDP) dedicated to discovering, developing, and delivering affordable and effective antimalarial drugs.

MMV collaborates with government agencies, private and public sector partners, and clinical centers in malaria-endemic regions to bring lifesaving solutions to the people most affected by malaria. Our work is made possible through funding from various sources, including government agencies, foundations, corporations, and individuals.

Join us in our mission to defeat malaria. As a strategic Regulatory Leader, you will play a pivotal role in shaping the development, approval, and post-approval evidence generation of life-saving antimalarial drugs across our innovative portfolio. This impactful position involves engaging with global regulatory authorities and key stakeholders, particularly in support of African regulatory harmonization efforts, while ensuring unwavering compliance with international standards to bring effective antimalarials to those who need them most.

If you are a seasoned regulatory expert with a passion for global health, a proven track record of navigating complex regulatory landscapes, and a collaborative spirit to drive impactful change, we encourage you to apply. 

Primary Duties and Responsibilities

Regulatory Leadership & Intelligence:

• Develop and execute regulatory strategies for the development, approval, and post-approval evidence generation of antimalarial drugs in MMV’s portfolio, ensuring alignment with global and local regulatory requirements
• Critically assess development plans and study designs ensuring compliance with SRA requirements, while identifying challenges/gaps and mitigating the risks
• Lead or co-lead with MMV partners, preparatory activities for interactions with regulatory authorities and WHO ensuring robust justification for development approaches,registration and policy adoption 
• Monitor and influence when possible evolving regulatory landscapes and policy changes, integrating emerging trends in into development strategies, clinical trial designs, and risk mitigation frameworks

Regulatory Implementation: 

• Provide regulatory leadership and hands-on expertise by drafting, compiling, and submitting key regulatory documents (eg. IBs, IMPDs, DSURs, clinical study protocols, critical non-clinical studies) where MMV is the sponsor or effective review when partner organization is the sponsor, ensuring alignment with program objectives and MMV’s strategy
• Establish and oversee the selection and management of external regulatory consultancies, when required, ensuring execution of deliverables 
• Align MMV’s approaches with AMA’s harmonization efforts and the African Union’s Pharmaceutical Manufacturing Plan for Africa

Stakeholder & Team Engagement

• Build and maintain strong relationships with global regulatory experts, industry partners, fellow Product Development Partnership (PDP) organizations and NGOs to stay ahead of evolving requirements
• Support our engagement with key innovation funders (for both R&D and access) to ensure that we share a common vision on optimal regulatory pathways including those in malaria endemic countries, to achieve maximal impact for next-generation products
• Foster effective communication by sharing expertise and learnings across project teams at MMV and partner organizations 
• Lead by example embracing MMV values, manage and develop direct report(s)

Qualifications and Skills

Education and Experience

• PharmD, PhD in life sciences or related field
• 15+ years of regulatory experience within pharmaceutical industry or biotech with proven track record of successful drug regulatory submissions and interactions with global health authorities in R&D and post-approval. Experience with injectable products is a plus. 
• Experience with stringent regulatory authorities (EU and/or US) is required, experience with malaria endemic countries regulatory authorities would be highly valuable
• Experience leading regulatory strategies for early-stage and late-stage development programs. 
• Experience in drug combinations development, paediatric development and/or infectious diseases would be highly valuable
• Experience with global public health normative bodies (e.g., WHO disease departments) and WHO prequalification processes would be highly desirable, as well as experience in engaging with LMIC policy-regulatory review processes.

Technical Skills

• Be willing to take a “hands on” approach to the role
• Highly skilled in writing, presenting, leading meetings and interacting with teams, external stakeholders and regulatory agencies
• Ability to thrive in a fast-paced, innovative environment and manage multiple priorities
• Excellent knowledge of drug development and ICH Good Clinical Practice standards 
• Comfortable working with multiple complex partnerships and with cross-functional project teams 
• Fluent in English (oral and written); French and/or other languages is an asset.
• Fully versed in all relevant IT tools

Behavioural Skills

• Strong leadership in both regulatory and health policy environment
• Excellent verbal and written communication skills
• Strong influencing and negotiations skills
• Demonstrate flexibility, dedication, and problem-solving attitude
• Excellent interpersonal skills with ability to interface well with international organization and external partners
• Willingness to travel up to 10%

If you are a driven regulatory leader eager to contribute to global health, with a strong track record and ideally, experience in malaria drug development and regulation in endemic countries, we invite you to bring your expertise to our mission.

Location: Geneva, Switzerland

Starting date: asap

Interested applicants should send their CV and a motivation letter explaining their interest in the position.

MMV is committed to building a talented and diverse workforce, selecting candidates based on their skills, abilities, and experience. We foster an inclusive workplace, free from discrimination on the basis of race, color, religion, political beliefs, age, nationality, disability, gender, or sexual orientation.

Our hybrid working model encourages in-office collaboration. For candidates residing in Switzerland, we expect a minimum of two days per week in the office; for cross-border candidates residing in France, at least three days per week. Please note that this is not a remote role, and MMV offers relocation support for highly qualified candidates.

For more information about MMV’s activities please refer to our website www.mmv.org

Non-mandated recruitment agencies are kindly requested to refrain from submitting applications.