Regulatory Specialist for Vaccine and Biotherapeutic Products

vor 3 Wochen

Genf, Genf, Schweiz WHO Vollzeit

Job Summary

This position is for a Regulatory Specialist who will work with the WHO Prequalification and Assistance (PQA) Unit to provide technical assistance to manufacturers of vaccines and biotherapeutic products. The incumbent will assist in organizing and/or providing WHO PQ/EUL-related specialized technical assistance, contribute to the development of standard operation procedures, and facilitate on-site reviews of dossiers for compliance with current WHO/international standards.

Key Responsibilities

  • Organize and/or provide WHO PQ/EUL-related specialized technical assistance for up to 5 manufacturers with on-site/virtual training and/or technical assistance on the quality/CMC, non-clinical and/or clinical aspects, post-marketing safety obligations including RMP and collection of AEFIs, and dossier of vaccines and other biotherapeutic products and prepare the relevant materials (reports, concept note, agenda).
  • Contribute with technical input for standard operation procedures for provision of WHO PQ-related specialized technical assistance to manufacturers of vaccines and other biotherapeutic products, or other LPA-related activities (organizing training) and prepare the relevant documents (SOP documents).
  • Facilitate organizing and/or conducting on-site reviews of dossiers of vaccines and/or biotherapeutic products for compliance with current WHO/international on standards and requirements of quality, non-clinical, clinical and/or post-marketing safety, including for WHO PQ/EUL, to up to 2 countries and prepare the relevant documents, materials (reports).
  • Organize and conduct at least 1 capacity building activities and technical assistance activities, for relevant stakeholders in the areas of CMC/quality, non-clinical, clinical and/or post-marketing safety documentation etc. of vaccines and/or biotherapeutic products with the relevant documents (concept note, agenda) and prepare the relevant documents (concept note, agenda).
  • Facilitate the preparation of training materials related on the quality/CMC, non-clinical, clinical and/or post-marketing safety aspects of vaccines and/or other biotherapeutic products and delivery of relevant training materials.
  • Contribute with technical inputs on the technical products of the LPA Unit, such as frequently asked questions documents, with collaboration from relevant colleagues and prepare of relevant documentations (FAQ).

Qualifications, Experience, Skills and Languages

Qualifications

  • Advanced university degree in pharmacy, health sciences, life sciences, or other science or health related fields.

Experience

  • At least seven years of relevant experience, some of which at the international level, in the production, CMC, quality control, non-clinical and/or clinical development, post-marketing safety documentation and dossier preparation for vaccines and/or biotherapeutic products under current international quality standards.

Skills

  • Strong knowledge of the manufacturing processes, CMC, non-clinical and/or clinical development, post-marketing safety documentation and product dossier requirements of vaccines and/or biotherapeutic products in accordance with WHO and/or internationally recognized standards.
  • Knowledge of current WHO and other internationally recognized quality assurance standards, WHO emergency listing and/or prequalification procedures and/or health product regulation for vaccines and/or biotherapeutic products.
  • Ability to review, revise or develop technical documents and activities in the area of local production of medical products.
  • Ability to design, plan and implement activities to achieve the goal(s).
  • Excellent communication and interpersonal skills, strong planning and organizational skills and ability to use a range of IT tools (Word, Excel, presentation software, databases and web navigators).

Languages

  • Expert knowledge of English.

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