SPO, Regulatory Affairs
Location: Seattle, WA, US
Position Title SPO, Regulatory Affairs
Division Global Health Program
Department Vaccine Delivery
Location Seattle
Foundation Overview
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people-especially those with the fewest resources-have access to the opportunities they need to succeed in school and life. Based in Seattle, the foundation is led by CEO Jeff Raikes and co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
Group Summary
The mission of the Gates Foundation's Global Health Program (GH Program) is to help ensure that lifesaving advances in health are created and shared with those who need them most. To date, we have committed nearly $10 billion in global health grants to organizations worldwide. The focus of our grants is to:
- Discover new insights to fight serious diseases and other health problems affecting developing countries.
- Develop effective and affordable vaccines, medicines, and other health tools.
- Deliver proven health solutions in developing countries.
- Advocate for more and better resources and policies to support the introduction and uptake of new and existing health technologies.
Responsibilities
The GH Program seeks a Senior Program Officer (SPO), Regulatory Affairs in the New Vaccine Introduction (NVI) / Vaccine Delivery group, which works across the GH Program supporting multiple teams. The SPO will be based in Seattle, Washington, and carry out responsibilities as outlined below. All responsibilities are expected to be executed in partnership with GH program teams in Seattle.
The GH Regulatory Affairs team is responsible for ensuring that the health technologies (vaccines, drugs, medical devices/diagnostics, etc.) that the foundation has invested in meet the designation of “right” product, rapidly developed, and approved to achieve maximum introduction, uptake, and health impact.
The team provides regulatory support for product development, approval, launch, and post-licensure activities. In addition, the team supports specific countries and regions to enhance the capacity of National Regulatory Authorities (NRAs), and regional regulatory initiatives. Finally, the team supports global efforts to ensure products procured by UN agencies for use in the poorest countries in the world meet international standards of quality, safety, and efficacy. The team works closely with multiple teams within the foundation's GH Program, and externally with grantees and partners.
Primary responsibilities include:
- Support Senior Regulatory Affairs Officer in the overall implementation of the GH regulatory strategy and priorities.
- Support the foundation's disease-specific Strategic Product Teams (SPTs) on regulatory policy, intelligence, and requests relevant to product development, registration, and post-licensure activities.
- Contribute to regulatory capacity strengthening across the Product Development Partnerships (PDP) supported by the foundation.
- Collaborate with WHO on enhancing developing country NRA and regional capacities.
- Support global efforts to ensure timely prequalification of priority foundation-funded products for UN purchasers and priority post-licensure activities.
- Represent the foundation in discussions of regulatory affairs relevant to specific products, NRAs, regional initiatives, and global efforts.
- Contribute to the development, review, and management of grants and contracts deemed necessary to achieve our goals.
Qualifications
- A minimum of 10 years experience in Regulatory Affairs for Vaccines, Biologics, Drugs, or Devices (Diagnostics); expertise in vaccine preventable diseases or HIV, TB, Malaria, and pneumonic and enteric infections is preferred.
- Demonstrated experience in the following:
o Regulatory meetings, briefing preparations, and submissions in fully functional regulatory authorities, including the EMA, US FDA, Health Canada.
o Global regulatory product development strategies including pre-registration, registration, and post-marketing activities in low- and middle-income countries is a plus.
- WHO prequalification experience preferred but not required.
- An advanced degree in bio-pharmaceutical or medical science.
- Ability to work with people with varied and diverse backgrounds and in dynamic environments.
- Ability to work with people in a matrix team environment through influence and without authority.
- Commitment to foundation's core values, mission and programs, and to the GH Program's core values.
- Excellent problem solving skills.
- Excellent written and oral communication skills.
- Ability to travel up to 30% domestically and internationally.
- Self-motivated and self-managing.
- A sense of humor.
As part of our standard hiring process for new employees, employment with the Bill & Melinda Gates Foundation will be contingent upon successful completion of a comprehensive background check.
Requisition Number 2502BR
Division Global Health Program
Department Vaccine Delivery
Location Seattle
Foundation Overview
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people-especially those with the fewest resources-have access to the opportunities they need to succeed in school and life. Based in Seattle, the foundation is led by CEO Jeff Raikes and co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
Group Summary
The mission of the Gates Foundation's Global Health Program (GH Program) is to help ensure that lifesaving advances in health are created and shared with those who need them most. To date, we have committed nearly $10 billion in global health grants to organizations worldwide. The focus of our grants is to:
- Discover new insights to fight serious diseases and other health problems affecting developing countries.
- Develop effective and affordable vaccines, medicines, and other health tools.
- Deliver proven health solutions in developing countries.
- Advocate for more and better resources and policies to support the introduction and uptake of new and existing health technologies.
Responsibilities
The GH Program seeks a Senior Program Officer (SPO), Regulatory Affairs in the New Vaccine Introduction (NVI) / Vaccine Delivery group, which works across the GH Program supporting multiple teams. The SPO will be based in Seattle, Washington, and carry out responsibilities as outlined below. All responsibilities are expected to be executed in partnership with GH program teams in Seattle.
The GH Regulatory Affairs team is responsible for ensuring that the health technologies (vaccines, drugs, medical devices/diagnostics, etc.) that the foundation has invested in meet the designation of “right” product, rapidly developed, and approved to achieve maximum introduction, uptake, and health impact.
The team provides regulatory support for product development, approval, launch, and post-licensure activities. In addition, the team supports specific countries and regions to enhance the capacity of National Regulatory Authorities (NRAs), and regional regulatory initiatives. Finally, the team supports global efforts to ensure products procured by UN agencies for use in the poorest countries in the world meet international standards of quality, safety, and efficacy. The team works closely with multiple teams within the foundation's GH Program, and externally with grantees and partners.
Primary responsibilities include:
- Support Senior Regulatory Affairs Officer in the overall implementation of the GH regulatory strategy and priorities.
- Support the foundation's disease-specific Strategic Product Teams (SPTs) on regulatory policy, intelligence, and requests relevant to product development, registration, and post-licensure activities.
- Contribute to regulatory capacity strengthening across the Product Development Partnerships (PDP) supported by the foundation.
- Collaborate with WHO on enhancing developing country NRA and regional capacities.
- Support global efforts to ensure timely prequalification of priority foundation-funded products for UN purchasers and priority post-licensure activities.
- Represent the foundation in discussions of regulatory affairs relevant to specific products, NRAs, regional initiatives, and global efforts.
- Contribute to the development, review, and management of grants and contracts deemed necessary to achieve our goals.
Qualifications
- A minimum of 10 years experience in Regulatory Affairs for Vaccines, Biologics, Drugs, or Devices (Diagnostics); expertise in vaccine preventable diseases or HIV, TB, Malaria, and pneumonic and enteric infections is preferred.
- Demonstrated experience in the following:
o Regulatory meetings, briefing preparations, and submissions in fully functional regulatory authorities, including the EMA, US FDA, Health Canada.
o Global regulatory product development strategies including pre-registration, registration, and post-marketing activities in low- and middle-income countries is a plus.
- WHO prequalification experience preferred but not required.
- An advanced degree in bio-pharmaceutical or medical science.
- Ability to work with people with varied and diverse backgrounds and in dynamic environments.
- Ability to work with people in a matrix team environment through influence and without authority.
- Commitment to foundation's core values, mission and programs, and to the GH Program's core values.
- Excellent problem solving skills.
- Excellent written and oral communication skills.
- Ability to travel up to 30% domestically and internationally.
- Self-motivated and self-managing.
- A sense of humor.
As part of our standard hiring process for new employees, employment with the Bill & Melinda Gates Foundation will be contingent upon successful completion of a comprehensive background check.
Requisition Number 2502BR
Nearest Major Market: Seattle
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