Drugs for Neglected Diseases initiative (DNDi) – Regulatory Affairs Consultant (Nairobi).

Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

DNDi Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programmes. This DNDi regional office conducts R&D projects in the Eastern Africa region (esp. Kenya, Uganda, Sudan, Ethiopia, Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma, and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approx. 35 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.

Purpose of the position

This position supports the Regulatory Affairs team which provides strategic regulatory guidance throughout the different stages of development, managing global regulatory activities for the DNDi portfolio in collaboration with the project teams in order to ensure timely availability to the patients where they need treatments, and interacts effectively with several partners and stakeholders to ensure that DNDi’s mission is fully reflected in the agreed regulatory strategy.

Specific job responsibilities

• Provide regulatory support and advice to disease and regional clinical operations on clinical trial requirements and dossier requirements for national and regional submissions
• Monitor progress of assigned regulatory projects/deliverables within established timeframes and ensure appropriate filing & archiving
• Participate in the review of non-clinical and clinical study protocols to ensure alignment with global regulatory requirements
• Support the preparatory activities including briefing package writing for interactions with regulatory authorities and lead or co-lead face to face meetings
• Interact as appropriate with internal and external stakeholders to optimize access timing of new medicines for patients
• Support regulatory affairs unit and DNDi processes
• May support Head of Regulatory Affairs in other delegated tasks (not specific to Africa)

Reporting line

• S/he reports to the Head of Regulatory Affairs based in Geneva
• Close working relationship with the assigned disease and clinical operation regional teams to deliver new treatments for neglected diseases in the DNDi portfolio

Skills and attributes

• Fluency in English and French
• Strong knowledge of African Regulatory environment of drug development & registration; understanding of regulations, laws, guidelines, and requirements
• Strong ability to coordinate projects, monitoring milestones, to achieve objectives under required tight timelines
• Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Strong ability to travel and work in the field
• Can do attitude – make things happen
• Open to change and willingness to learn
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
• Strong communication skills in multicultural, multi-lingual environments
• Well organized and structured
• Strong analytical skills
• Strong ability to provide high level support in project/programme delivery
• Strong management, negotiation, and advocacy skills
• Strong autonomy as the only regulatory expert locally
• Ability to work effectively in a multinational virtual team and to interact with internal/external stakeholders (partners, consultants, etc.)
• Technical writing/review skills (briefing books, protocol/report review, etc.)

Experience

• Minimum 7 years’ relevant experience
• Experience of interacting with different regulatory authorities in Africa and other countries. Experience with stringent regulatory authorities (EMA, FDA…) and joined regional initiatives will be an advantage.
• Proven experience in offering regulatory support to clinical trials
• Experience of working in public and private sector is desirable

Education

• Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level in relevant field

To apply

• Please submit your application using this link APPLY
• Deadline for application: Accepting applications until 16 March 2021
• Only shortlisted candidates will be contacted
• Application submission for this position may close early if we have enough suitable applicants