Consultant for Collaborative Registration Procedure

Job Posting Organization:
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. Established on April 7, 1948, WHO has a mission to promote health, keep the world safe, and serve vulnerable populations. The organization operates in over 150 countries and has more than 7,000 employees worldwide. WHO's primary goal is to ensure that all people can attain the highest possible level of health, and it works with countries to strengthen their health systems and improve health outcomes.

Job Overview:
The Consultant will play a crucial role in supporting Member States' activities related to facilitated product introduction mechanisms, particularly through the Collaborative Registration Procedure (CRP). This position involves building the capacity of marketing authorization functions and assessing marketing authorization applications in accordance with WHO and international standards. The Consultant will assist national regulatory authorities (NRAs) in implementing WHO's CRP, engage in outreach to additional countries, and support regional ASEAN joint assessment activities and Global Health Products Procedures. The role requires a deep understanding of regulatory reliance mechanisms and the ability to advocate for and implement these processes effectively across various countries in the region.

Duties and Responsibilities:
The Consultant's responsibilities include advocating for and supporting national regulatory authorities in the implementation of reliance mechanisms and the WHO Collaborative Registration Procedure. Specific duties include providing technical support to countries for efficient implementation, responding to technical inquiries from NRAs, facilitating training and guidance through WHO HQ, and assisting NRAs in developing and updating policies and guidelines. The Consultant will also follow up on CRP submissions, support the collection of CRP metrics, and ensure the electronic prequalification system is up to date. Additionally, the Consultant will arrange outreach to new countries, provide technical support for regional joint assessments, and help collect metrics for joint activities in collaboration with WHO HQ.

Required Qualifications:
Candidates must possess a first university degree in pharmaceutical sciences or a related field. An advanced university degree (master’s level or above) in pharmaceuticals, pharmacology, or a related field is desirable. Essential qualifications include at least five years of professional experience in the regulation of medical products, particularly in marketing authorization, and experience working in a national regulatory authority or relevant institutions. Familiarity with regulatory facilitated pathways, including WHO's CRP, is crucial. Experience in conducting meetings, workshops, and training sessions, as well as preparing technical reports, is also required.

Educational Background:
The educational background required for this position includes a first university degree in pharmaceutical sciences or a related field. An advanced degree, such as a master's or higher, in pharmaceuticals or pharmacology is preferred, indicating a higher level of expertise in the relevant field.

Experience:
The position requires a minimum of five years of professional experience in the regulation of medical products, specifically in marketing authorization. This experience should be gained through work in a national regulatory authority, a pharmaceutical or biological manufacturer, or other relevant institutions. Proven familiarity with regulatory facilitated pathways and mechanisms, including WHO's Collaborative Registration Procedures, is essential. Experience in facilitating and conducting regulatory capacity-building activities is also important.

Languages:
Expert knowledge of English is mandatory, including reading, writing, and speaking skills. Proficiency in additional languages may be considered an advantage but is not explicitly required for this position.

Additional Notes:
The Consultant will be expected to travel for CRP advocacy workshops, technical support visits to NRAs, and other relevant meetings. This vacancy notice may also be used to identify candidates for similar consultancies at the same level. Candidates under serious consideration will be contacted, and a written test may be used as part of the screening process. Candidates must provide scanned copies of their educational qualifications upon request. WHO is committed to diversity and inclusion and encourages applications from women, persons with disabilities, and nationals of underrepresented Member States. The organization has a zero-tolerance policy towards sexual exploitation and abuse, and all members of the workforce are expected to promote a safe and respectful workplace.