[Closing date: 20 October 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 position
The Regulatory Affairs department 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.
The Senior Regulatory Affairs Manager provides critical support to achieve Regulatory Affairs department goals.
Specific job responsibilities
- Act as an in-house regulatory expert, advising and supporting the disease teams
- Lead the preparatory activities including documentation (e.g. briefing package) writing and compilation for interactions with regulatory authorities (eg. pre-IND, scientific advice, paediatric plans etc.) and may lead or co-lead face to face meetings
- Provide regulatory support to disease teams on clinical trial requirements, review critical documents intended for submission to regulatory authorities such as IBs
- Interact upon delegation by Head of Regulatory Affairs with internal and external stakeholders, consultants, partners, and regulatory authorities
- Coordinate regulatory activities with pharmaceutical and other partners
- Provide regulatory support to disease teams on clinical development plans
- Support Head of Regulatory Affairs in Regulatory Intelligence related-activities, sharing relevant updates
- May support Head of Regulatory Affairs in other delegated tasks
- S/he reports to Head of Regulatory Affairs
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 ability to interact with internal and external stakeholders
R&D technical skills
- Very strong understanding of regulatory requirements and guidelines for filings in different regions/territories
- 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, National Regulatory Authorities)
- Proven ability to work effectively in a team environment and matrix structure, managing complex/virtual networks and partners
- Experience of working in public and private sector is highly desirable
- Professional experience as part of a regulatory agency would be useful
- Desirable: experience in diseases of DNDi R&D portfolio
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level or Pharmacy degree or Ph.D. in relevant field
- Degree/specialization in regulatory affairs
- Fluency in English
- Proficiency in local languages desirable
- Very good knowledge of Microsoft Suite
- Status: full time – permanent role
- Deadline for application: Accepting applications until 20 October 2019
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants