Head of Regulatory Affairs

Geneva, Switzerland 
[Closing date: 10 January 2020
]

 

The 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.

DNDi has a large portfolio of R&D activities covering seven 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 Head of Regulatory Affairs provides strategic regulatory guidance. S/he manages global regulatory activities for the DNDi portfolio in collaboration with the project teams in order to ensure timely availability of new treatments to the patients. S/he interacts effectively with several partners and stakeholders to ensure that DNDi’s mission is fully reflected in the agreed regulatory strategy.

 

Specific job responsibilities

  • Act as an in-house regulatory expert, advising and supporting the disease teams
  • Together with project teams and external stakeholders, support consistent regulatory strategy by regulatory authorities (stringent, NRAs, WHO prequalification, etc)
  • Lead the implementation of global regulatory strategies taking into consideration the overall development programme objectives
  • Lead the preparatory activities for interactions with regulatory authorities (e.g. scientific advice) and lead or co-lead face-to-face meetings
  • Manage and monitor preparation, submission, and review of regulatory documentation for those interactions in collaboration with disease team leaders
  • Coordinate with pharmaceutical partners to ensure that regulatory strategies and activities are consistent with the development programme objectives of DNDi‘s projects in line with our mission
  • Provide regulatory support to disease teams on clinical development plans and clinical trial requirement
  • Participate in the review of IBs, clinical study protocols (or synopsis), and critical non-clinical study protocols to ensure alignment with global regulatory requirements
  • Develop knowledge on the global regulatory environment and trends. Contribute to shaping and implementing the DNDi policy position in this field (e.g. mutual recognition, accelerated pathways, incentive mechanisms…)
  • Participate in any relevant product planning review when called by the disease initiatives
  • Participate in opportunity assessment to provide regulatory input on potential new projects with partners
  • Contribute to DNDi relevant technical, management, and governance committees (Leadership meetings, Scientific Advisory Committees, etc.)
  • Share regulatory intelligence for DNDi focusing on changes relevant to DNDi portfolio clinical development and cooperative review pathways for medicines development and registration in LMIC

 

Reporting line

  • S/he reports to the Medical Director

 

Job requirements

Skills and attributes

  • 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
  • Highly organized and structured
  • High analytical skills
  • High ability to lead large strategic projects
  • High ability to manage large size projects with budget management
  • Very strong strategic thinking and leadership abilities
  • Excellent management, negotiation, and advocacy skills
  • High ability to exercise high degree of independence to ensure programme delivery and explore new areas of activities
  • High ability to interact with internal and external stakeholders
  • High ability to lead and motivate a team for optimum performance

R&D technical skills

  • Very strong understanding of regulatory requirements and guidelines for filings in different regions/territories

Experience

  • Minimum 10 years’ regulatory experience in pharmaceutical development
  • Strong working experience with a variety of regulatory authorities is required, with real firsthand experience of managing registrations with different regulatory authorities (stringent, National Regulatory Authorities)
  • Experience in leading and managing complex/virtual networks suppliers and partners to deliver and maintain regulatory approvals is essential
  • Proven track record in influencing and shaping optimal regulatory outcomes
  • Experience building and leading teams in a start-up environment
  • Professional experience as part of a regulatory agency would be useful
  • Experience of working in public and private sector would be useful
  • Experience in diseases of DNDi R&D portfolio would be desirable

Education

  • Advanced postgraduate degree or graduate degree with equivalent experience to reach Master level or Pharmacy degree or Ph.D. in relevant field
  • Degree/specialization in regulatory affairs

Other requirements

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

 

Other information

  • Status: full time – permanent role

 

To apply

  • Deadline for application: Accepting applications until 10 January 2020
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants