Consultant (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's mission is to promote health, keep the world safe, and serve vulnerable populations. With over 7,000 employees and operations in more than 150 countries, WHO works to ensure that all people can attain the highest possible level of health. The organization focuses on various health issues, including disease prevention, health systems strengthening, and emergency response, and collaborates with countries to improve health outcomes.

Job Overview:
The Consultant (Collaborative Registration Procedure) will work under the supervision of the Unit Head for Medical Products Regulation and in close collaboration with WHO headquarters and country offices. The primary function of this role is to support Member States and regional networks, particularly the South-East Asia Regulatory Network (SEARN) and the ASEAN joint assessment, in facilitating product introduction mechanisms through reliance, specifically the Collaborative Registration Procedure (CRP). The consultant will assist in building the capacity of marketing authorization functions and the assessment of marketing authorization applications in accordance with WHO and international standards. This position requires a proactive approach to engage with national regulatory authorities (NRAs) to ensure the timely availability of safe, effective, and quality medical products.

Duties and Responsibilities:

• Attend induction meetings and develop an activity plan with the Unit Head and HQ counterpart within the first month.
• Provide technical support to national regulatory authorities in the region for the implementation of reliance mechanisms and WHO Collaborative Registration Procedure.
• Respond to technical inquiries from NRAs regarding evaluations or good manufacturing practices for specific products.
• Facilitate training and guidance for countries through the WHO HQ Special Access Programme.
• Assist CRP participating NRAs in developing and updating policies, regulations, guidelines, and tools for facilitated product introduction pathways.
• Maintain the SEARN reliance database and support regional work-sharing activities.
• Follow up on CRP submissions and timelines, ensuring effective communication with NRAs.
• Support outreach efforts to countries not currently participating in WHO CRP pathways.
• Provide technical support for regional joint assessments and activities, including metrics collection. 1
• Assist in global health products procedures and the involvement of NRAs in the region. 1
• Build capacity for marketing authorization functions in accordance with WHO's regulatory system strengthening programme. 1
• Perform any other relevant duties assigned by supervisors, ensuring comprehensive support across all budget centers.

Required Qualifications:
Essential qualifications include an advanced university degree (master’s level or above) in pharmaceuticals, pharmacology, or a related field. Candidates must have five to ten years of relevant professional experience in the regulation of medical products, either through work in an NRA or relevant institution, or in the medical products manufacturing industry. A proven ability to communicate effectively in diverse cultural settings, edit regulatory documents, and achieve stakeholder agreements on regulatory matters is essential. Experience in organizing and conducting meetings, workshops, and training activities is also required. Candidates should be proficient in preparing written reports and communication materials in English.

Educational Background:
Candidates must possess an advanced university degree (master’s level or above) in pharmaceuticals, pharmacology, or a related field. This educational background is crucial for understanding the complexities of medical product regulation and ensuring compliance with international standards.

Experience:
Candidates should have five to ten years of relevant professional experience in the regulation of medical products, with at least five years specifically in marketing authorization regulatory functions. Experience working with national regulatory authorities or in the medical products manufacturing industry is essential. The ability to communicate effectively and work collaboratively in diverse cultural settings is also required, along with experience in organizing regulatory capacity-building activities.

Languages:
Expert knowledge of English is mandatory. Knowledge of South-East Asian languages is desirable, as it would enhance communication and collaboration with regional stakeholders.

Additional Notes:
The position is based on-site at SEARO in New Delhi. The expected duration of the contract is 11 months, with remuneration set at Pay Band Level B - USD 77,000, depending on experience and the nature of work. Travel expenses and per diem will be covered as per WHO rules applicable to consultants for approved official travel during the contract period. This vacancy notice may also be used to identify candidates for other similar consultancies at the same level. Candidates under serious consideration will be contacted, and a written test may be used as a screening method. WHO is committed to diversity and inclusion in its workforce and encourages applications from women, persons with disabilities, and nationals of underrepresented Member States.