Company Information
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Company Name: National Institute of Allergy and Infectious Diseases (NIAID)
Website: http://www.nih.gov

Job Information
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Job Title: Chief, Office of Regulatory Affairs
Job Description:
The National Institute of Allergy and Infectious Diseases (NIAID), one of the
largest institutes in the National Institutes of Health (NIH), part of the
Department of Health and Human Services (HHS), conducts and supports basic
and applied research to better understand, treat, and ultimately prevent
infectious, immunologic, and allergic diseases. The Office of Regulatory
Affairs (ORA) in the Division of Allergy Immunology and Transplantation
(DAIT) within NIAID seeks an extraordinary and transformational leader to
serve as Chief of ORA.

DAIT is one of four extramural program divisions within NIAID and is
responsible for 1) the management and support of basic, preclinical, and
clinical research to understand, treat, and prevent immune-mediated diseases;
and 2) the development of medical countermeasures against radiation/nuclear
injuries.

ORA provides regulatory and quality assurance oversight to ensure that
DAIT-sponsored clinical trials are conducted in compliance with all
applicable national and international regulatory health authority regulations
and requirements to ensure the safety of patients and the integrity of the
trials.

The Chief of ORA provides strategic direction, guidance, and oversight of
regulatory science affairs issues to all DAIT staff and DAIT-supported
investigators. The responsibilities of the position are as follows:

•	Serve as the research sponsor’s authorized representative for DAIT-held
investigational new drugs
•	Direct and oversee the preparation and submission of regulatory health
authority application submissions, reports, and correspondence
•	Manage and oversee the administrative and budgetary matters of the
Regulatory Management Center contract, which provides critical regulatory
support to DAIT-sponsored research
•	Formulate and implement regulatory and quality assurance strategies to
ensure DAIT compliance with applicable state, national, and international
regulations
•	Monitor emerging trends and developments in the field of regulatory
science in the United States and Europe to determine the potential impact on
the organization
•	Develop and maintain professional relationships with regulatory health
authorities on the local, national, and international levels

Qualifications
Required
•	A doctoral degree (M.D., Ph.D.) or equivalent in the biological or
medical sciences
•	Expert knowledge of regulatory affairs with respect to the academic
research community, pharmaceutical industry, and federal regulatory agencies

Applicants must also demonstrate the following:
•	Strong strategic skills, including the ability to make complex decisions
and the willingness to defend difficult positions
•	Extensive knowledge of complex medical and scientific subject matter as
well as evolving regulatory policy and guidance
•	Experience providing effective budgetary and administrative oversight of
contract research organizations

U.S. citizenship is not required. The successful candidate will possess
leadership, management, interpersonal, and communication skills to interact
effectively with staff, academia, private industry, and national and
international research, health, and regulatory organizations.



Requirements:
To Apply
Interested candidates should send the following by email to
NIAID-DAIT-ORAChief-Apply@mail.nih.gov [1]:

•	Curriculum vitae that includes a brief description of your
responsibilities
•	Bibliography
•	A two-to-three-page statement describing your 1) experience and expertise
in developing effective and successful regulatory strategies to navigate
pathways for interactions with regulatory health authorities throughout the
lifecycle of a clinical trial, 2) reasons for your interest in the position,
and 3) leadership skills and experience you would bring to NIAID, including
your experience promoting a diverse workforce

As the recruitment process progresses, up to three professional letters of
reference may be required.

Applications will be accepted until October 19, 2023. For more information or
questions about the position, email NIAID-DAIT-ORAChief-Apply@mail.nih.gov
[2].

HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity,
equity, inclusion, and accessibility.


[1] mailto:NIAID-DAIT-ORAChief-Apply@mail.nih.gov
[2] mailto:NIAID-DAIT-ORAChief-Apply@mail.nih.gov



Resume Information
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Applicants should submit the following:: Resume
Majors Desired:: Health Sciences

Application Information
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Email application materials to:: NIAID-DAIT-ORAChief-Apply@mail.nih.gov