Regulatory Science Manager

The R&D organisation drives therapeutic innovation from the lab bench to the patient bedside.  It develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICs clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDi functions, beyond R&D. 

The R&D organisation include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases.  Integrated Clinical Development Sciences (Drug Safety & Pharmacovigilance, Clinical Quality Assurance and Translational Sciences), Regulatory Sciences, Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics.

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.  

Since our inception, DNDi has delivered 13 new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We aim to deliver a total of 25 new treatments by 2028– addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID-19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low- and middle-income countries.  

At DNDi, Regulatory Science is a transverse team that contributes to all DNDi programs by providing expertise and functional leadership including:

• Providing strategic regulatory guidance throughout the different stages of research and development and in access, managing global regulatory activities for the DNDi portfolio in collaboration with the project teams to ensure timely availability to the patients where they need treatments,
• Leading transversal regulatory sciences activities and provides solution for regulatory challenges to ensure timely access to effective, quality, safe and affordable medicines to neglected population
• Driving interaction with partners and stakeholders to ensure that DNDi’s mission is fully reflected in the regulatory strategy

Regulatory strategy

• Manages activities of regulatory sciences through lower management levels while establishing strategy for assigned DNDi projects to achieve optimal development and access,
• Develops strategic plans and regulatory risk assessments and create innovative regulatory solutions,
• Addresses issues, gaps, options, and trade-offs proactively for the development plan to increase the probability of an optimal and timely submission and approval,
• Coordinates regulatory activities with pharmaceutical and other partners,
• Ensures alignment of regulatory strategy with internal and external partners, stakeholders and consultants.

Interactions with Health Authorities

• Develops global regulatory strategy and plans for Health Authority (HA) interactions as appropriate,
• Contributes to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions,
• Leads the preparatory activities including briefing package writing for interactions with regulatory, authorities (e.g. pre-IND, scientific advice, EOPh2 etc.) and lead or co-lead face to face meetings.

Submissions, approvals and maintenance

• Provides regulatory and strategic input on clinical study protocols and protocol amendments,
• Independent and timely preparation/compilation as well as supervision of high-quality regulatory documentation during development/product registration to support complex regulatory submission (input to development plan, IMPD, Scientific advice briefing documentation, clinical study protocols, Investigator Brochure…),
• Combines knowledge of scientific, regulatory, and business issues to develop products to meet required global, regional and local regulatory requirements,
• Achieves timely submission/approvals.

Regulatory excellence and compliance with regulatory and DNDi/Regulatory Science policies

• Ensures regulatory science excellence (implementation and full compliance with processes and procedure),
• Prepares and updates SOP,
• Conducts trainings and education to increase regulatory compliance at DNDi and students worldwide
• Secures adherence of the company to regulatory requirements,
• Shares timely experience within regulatory team,
• Contributes/leads “trans-project” as per priorities and proactive support/actions to secure RA excellence.

Regulatory intelligence

• Takes an active role in developing knowledge and external footprint to contribute shaping and implementing DNDi policy position in the field,
• Acts as an in-house regulatory expert, advising and supporting, the assigned disease teams,
• Monitors the development of new regulatory authorities in support of proposed and ongoing development programs,
• Analyses, formulates and presents recommendations to disease teams under supervision from the regulatory sciences head or leader.

Management/team support

• Supports in a proactive manner the objectives of the regulatory team.
• Provides effective support to the regulatory team by providing mentorship and support to all members of the regulatory team,
• Ensures effective communication, sharing expertise, learnings across projects,
• Builds and maintains a strong knowledge management base (collection/sharing),
• Serves as role model embracing DNDi Values and Behaviors. Lead by example,
• Interacts with internal and external stakeholders, consultants, partners and regulatory authorities,
• Responsible in other activities/projects as per need,
• Ensures adherence to budget

• Regulatory Science Manager reports to Head of Regulatory Sciences.
• This role has frequent interaction with DNDi staff and external stakeholders to coordinate provision of work or to advocate, persuade and gain support or commitment. This role represents DNDi for a program/service area and develop and maintain relationship with current and future partners.

• 5+ years of relevant experience in Regulatory Affairs/Science, including preparation, submission and managing clinical trial applications in Europe and INDs in the US, marketing authorization applications in the EU and in the US.
• Regulatory experience of working in pharmaceutical industry with a focus on the clinical development
• Degree in Pharmacy, Medicine, Life Sciences or equivalent.

• High 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
• Excellent communication, and public speaking skills, ability to convince and represent DNDi at high level events
• Knowledge of managing global multicultural teams
• Excellent organizational skills with excellent attention to detail.
• Strong interpersonal and communication skills, ability to work in a fast-paced, multi-disciplinary environment.
• Proven ability to work effectively in a team environment and matrix structure
• High analytical skills
• High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
• High ability to interact with internal and external stakeholders

R& D Technical Skills

• Good knowledge of Drug Discovery
• Very Good knowledge of Clinical Research/Development
• Strong knowledge of the current European and US regulations, laws, guidelines and industry requirements
• Excellent knowledge of 1-2 stringent Regulatory bodies (e.g. EMA , Swissmedic, US-FDA)
• Proven ability to manage regulatory submissions (including interactions with authorities) for new medicines.
• Good knowledge of neglected Disease/academia knowledge
• Excellent Technical writing skills (procedures, briefing documentation, protocols and reports)

• Fluency in English
• Proficiency in local languages desirable
• Good knowledge of Microsoft Suite

DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.