Requirements: English
Company: WhatJobs
Region: Geneva , Geneva
Medicines for Malaria Venture (MMV) is the worlds 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 MMVs 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 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 (e.g., 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 MMVs strategy.
- Establish and oversee the selection and management of external regulatory consultancies, when required, ensuring execution of deliverables.
- Align MMVs approaches with AMAs harmonization efforts and the African Unions 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.
- More than 10 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, pediatric 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