Regulatory Expert

As an ideal candidate for this position, you should possess approximately 10 years of general experience and at least 7 years of relevant experience in regulatory affairs and research & development. Your background should include a strong knowledge of vaccine regulations, as well as hands-on experience in vaccine projects. Your primary responsibilities will include supporting human resource mapping and capacity building activities for National Regulatory Authorities (NRAs) in the country, tailored to their status as Vaccine Producing or Importing entities. You will be involved in NRA assessment and benchmarking, particularly for CDSCO in India and BFDA in Bhutan. Additionally, you will provide technical assistance in drafting institutional development plans and developing mechanisms for NRAs self-assessment and Quality Management Systems implementation to achieve specific statuses. In terms of qualifications, a master's degree in life sciences, public health, health systems, or related fields is preferred for this role. Your expertise will contribute significantly to the expedited marketing authorization procedures and emergency use authorization processes during pandemic situations. Overall, success in this position will be demonstrated by your ability to effectively support NRAs in enhancing their regulatory capabilities, ensuring compliance with vaccine regulations, and facilitating the implementation of Quality Management Systems for achieving specific status levels. Your contributions will play a vital role in the organization's goal of strengthening regulatory affairs and research & development activities in the field of vaccines.,