[Closing date: 3 February 2019]
Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)
DNDi has a large portfolio of R&D activities covering 7 disease areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, mycetoma, paediatric HIV, and hepatitis C. R&D projects are driven by patients’ medical needs for each disease area that in turn set strategy and scientific approaches.
DNDi does not have any research facilities and does not directly conduct research to develop its treatments. DNDi follows a virtual research model, whereby most research is outsourced with the R&D projects actively managed by DNDi personnel who are experienced in different aspects of pharmaceutical development.
DNDi proactively identifies research opportunities that have the highest potential to be translated into improved treatment options, then sources the research project into its portfolio, builds the full development plan, identifies, and contracts the appropriate partners for each step in the development process, and manages the efficient advancement of the project throughout the pipeline.
Over half of the R&D staff are located in Geneva working in close collaboration with disease-specific R&D teams operating in regional offices located in Africa, Asia, and South America.
Purpose of the mission
DNDi is seeking a senior full time consultant with expertise in regulatory affairs that has accomplished senior roles in managing new medicines registrations with different regulatory authorities (stringent, NRAs) and a very strong understanding of regulatory requirements and guidelines in different regions.
S/he has the responsibility to support dossier preparation for new medicine registration application. During this work, s/he may interact when appropriate and under the direction of the Head of Regulatory with internal and external stakeholders, consultants, partners, and regulatory authorities.
The Senior Consultant will act as a regulatory expert, advising, and supporting the disease team and the Head of Regulatory Affairs in the interactions with regulatory authorities (including briefing packages preparation), in the review of clinical study protocols, critical non-clinical studies, clinical development plan, and clinical trial requirements to ensure alignment with global regulatory requirements.
Skills and attributes
- 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 English writing 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 ability to exercise high degree of independence to support programme delivery and explore new areas of activities, including potential relevant innovative collaborative regulatory pathways
- Very strong understanding of regulatory requirements and guidelines for filings in different regions/territories
- Very strong ability to interact with internal and external stakeholders
- Minimum 8 years’ regulatory affairs experience in pharmaceutical development with Senior role experience in medicine registration
- Experience of managing registrations with different regulatory authorities
- Experience with different regulatory authorities (stringent, NRAs)
- Professional experience as part of a regulatory agency would be useful
- Experience in diseases of DNDi R&D portfolio is desirable
- Degree/specialization in regulatory affairs
- Status: 1 year – full time – consultancy position with external salary hosting company
- Swiss nationality, B, C or G permit
- Deadline for application: Accepting applications until 3 February 2019
- Only shortlisted candidates will be contacted