Summary of the Position

The Technical Advisor, Regulatory Systems Strengthening (RSS) will provide technical assistance to the medicines regulatory authorities and Ministries of Health in South Asia.  The incumbent’s primary objective will be to strengthen the capacity of these organizations to ensure the quality of medical products circulating in the region.  The person will also assume the role of regional lead for RSS and will provide guidance and support to technical staff in the region working on dossier review/market authorization, inspections, other regulatory functions and policy development. They must possess a deep understanding of the pharmaceutical regulatory environment in low income and middle-income countries in South Asia to provide technical oversight to the MRAs of varying maturity level.  The incumbent should be a recognized thought leader and will also work with manufacturers located throughout the region to raise their level of compliance with current good manufacturing practices and support those seeking WHO prequalification.  The Technical Advisor will also contribute to the PQM+ Center of Excellence through the development and dissemination of new approaches to advance the technical work of the program and will have functional reporting to the Senior Technical Advisor - RSS located in Rockville.

Roles and Responsibilities

• PQM+ regulatory systems strengthening lead in the Asia region.
• Leads in the development of medicines regulatory policies impacting medicine quality and will work with the heads of MRAs and MoH to develop policies enabling the growth of the pharmaceutical sector in south Asia.
• Leads PQM+’s effort in supporting Association of Southeast Asian Nations (ASEAN) and South-East Asia regulatory network) SEARN regional initiatives.
• Advises MRAs on interventions to address institutional development plans based on the findings of WHO Global Benchmarking assessments of African countries
• Provides technical support to manufacturers seeking WHO prequalification
• Primary technical resource for technical staff in Asia
• Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge
• Supports the PQM+ Center of Excellence in developing and disseminating PQM+ approach documents related to market authorization, inspections, post-marketing surveillance, quality management systems and quality assurance/quality control 
• Supports the Technical Director and Sr. Technical Advisor in the development of PQM+ technical approach tools
• Keep abreast of the latest regulatory trends and WHO guidance
• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
• May mentor junior technical staff
• Represents program in regional meetings

Basic Qualifications

• B.S. in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering or related field
• Ten (10) years’ experience in pharmaceutical regulatory affairs or manufacturing.    
• Working knowledge and understanding of the norms and practices of pharmaceutical systems in Asia. 

Skills Sough

• Strong written (especially technical writing) and oral communication skills
• Direct experience with and understanding of WHO global benchmarking tool
• Willingness to travel at least 25% of the time.

  Preferred Qualifications

• Demonstrated experience working and leading various departments in a national medicines regulatory authority, pharmaceutical manufacturer or organization providing technical assistance to strengthen medicines quality assurance systems
• Direct experience implementing USAID-funded programs
• Demonstrated people management experience and skills