International Consultant - Collaborative Registration Procedure

The Consultant will support Member States and regional networks, especially the South-East Asia Regulatory Network (SEARN) and ASEAN joint assessment, in activities related to facilitated product introduction mechanisms through reliance, particularly the Collaborative Registration Procedure (CRP). The role involves building capacity of marketing authorization functions and assessment of marketing authorization applications according to WHO and international standards.

Responsibilities

• Support national regulatory authorities in the region with implementation of reliance and WHO Collaborative Registration Procedure through SEARN and ASEAN.
• Provide technical support to countries for efficient implementation of reliance mechanisms and CRP.
• Respond to NRA technical questions on evaluation or GMP status and liaise with WHO HQ as necessary.
• Facilitate and support WHO HQ Special Access Programme for training and guidance.
• Support development, revision and updating of policies, regulations, guidelines and tools for facilitated product introduction pathways and CRP implementation.
• Support development and maintenance of SEARN reliance database.
• Support regional worksharing/convergence marketing authorization activities through SEARN.
• Coordinate and manage related SEARN groups.
• Follow-up CRP submissions and timelines, assist NRAs with questions, and maintain electronic prequalification system (ePQS) for CRP submissions.
• Advocate for CRP participation in countries not currently involved, in collaboration with WHO HQ and country offices.
• Support regional joint assessment and joint activities, especially through SEARN.
• Support global health products procedures and involvement of NRA experts in the region.
• Support capacity building for marketing authorization function and assessment of marketing authorization applications according to international standards.
• Assist WHO Collaborating Centres and SEARN Regional centers of excellence in curriculum and training material development.
• Perform other relevant duties as assigned by supervisors.

Requirements

• Advanced university degree (master’s level or above) in pharmaceuticals/pharmacology or related field.
• Five to ten years of relevant professional experience in regulation of medical products, preferably working in an NRA or relevant institution or medical products manufacturing industry with significant regulatory experience and engagement with NRAs.
• At least five years of experience in marketing authorization regulatory function.
• Proven ability to communicate and work in diverse cultural settings, edit regulatory documents, and contribute to agreements among stakeholders on regulatory matters for medical products.
• Experience in organizing, facilitating and conducting meetings, workshops, trainings, or regulatory capacity building activities.
• Experience in preparing written reports, communication materials, and other documents in English.
• Desirable: Significant experience in GMP/GCP inspections.
• Desirable: Significant experience in South-East Asia.
• Proven ability to handle projects.
• Good organizational skills.
• Computer proficiency in office environment (Excel, Word, PowerPoint).
• Proven familiarity with regulatory facilitated pathways and mechanisms including WHO Collaborative Registration Procedures (CRP) and/or novel regulatory pathways.
• Expert knowledge of English.
• Desirable: Expert knowledge of South-East Asian language(s).

Skills

• Pharmaceutical Regulatory Requirements
• Medical Products Regulation
• Marketing authorization
• Regulatory document editing
• Stakeholder Engagement
• Meeting Facilitation
• Workshop Organization
• Regulatory capacity building
• Report Writing
• GMP Inspections
• GCP Inspections
• Project Management
• Office Software Proficiency
• WHO Collaborative Registration Procedure
• Regulatory Pathways
• English Language Proficiency

Languages

English