PATH Vacancies; Regulatory Officer

Regulatory Officer, HIV, Indonesia
Tracking Code
9873
Job Description
NOTE: This position is contingent upon donor funding. Indonesian nationals are encouraged to apply

PATH is recruiting for a Regulatory Officer for an anticipated HIV testing project with the goal of creating and enabling environment in Indonesia to offer a wide range of testing options across several contexts, such as health facilities and community-based settings. The Regulatory Officer will collaborate with several stakeholders to facilitate meetings, processes, gather information, and conduct other activities as necessary.

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.

PATH will work with local stakeholders to expand the range of HIV testing options. The project will provide the data necessary to make a variety of tests available to HIV programs across Indonesia. The Regulatory Officer will conduct an HIV test landscape analysis, research registration and importation processes, seek expert recommendations, collaborate with government stakeholders and others to inform a roadmap for advancing HIV testing in Indonesia. 


Responsibilities:

Research the different diagnostic regulatory process per Indonesian guidelines, including identifying national and international performance standards
Identify investigational device regulations, processes, and import controls for Indonesia
Prepare reports for the project and external stakeholders
Provide recommendations and guidance for regulation and registration of diagnostics
Coordinate and lead meetings with key stakeholders in Indonesia, including regulatory governing bodies, manufacturers, and national and global HIV testing policy/decision-makers
  
Required Experience

Bachelor’s degree in life sciences, technology, or engineering preferred
Knowledge of Indonesian diagnostic regulatory processes and at least three to five years of experience in regulatory issues and diagnostics
Prior experience with product registration a plus
Excellent ability to articulate oral and written technical information clearly and effectively to both technical and non-technical audiences
Strong analytical, presentation, communication, and reporting skills
Oral and written fluency in English required
  
Must have legal authorization to work in Indonesia.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, gender identity or orientation, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
  
Job Location
Jakarta, Indonesia
Company Location
Indonesia, Jakarta
Position Type
Full-Time/Regular