Job Title: Regulatory Affairs Intern
Location: New York, NY
Reports to: Senior Director or Director Regulatory Affairs
Position Summary:
Provide support to the regulatory department to ensure maintenance and organization of regulatory files (electronic and paper) for proper tracking of information and archiving of regulated documents.
Key Responsibilities:
• Audit and update of regulatory correspondence files/logs, and submission archives
• Shadow RA personnel to learn drug development process in a real-world environment
• Participate in dossier preparation and submission
Education, Experience and Skills:
• Current Bachelors of Science or Masters Degree student in RA or equivalent formal training in ICH Common Technical Document (CTD) format.
• Demonstrates interest in FDA regulated environment as applies to drug development for clinical trials.
• Interest in vaccines/biologics preferred.
• Demonstrates interest in electronic database management and structured information storage (archiving).
• Must be a good written and oral communicator.
• Must have strong attention to detail and demonstrated personal or professional experience with orderly information cataloging and retrieval. Ability to work independently, establishing project milestones and reporting.
• Awareness of processes for working in a regulated field for information management (banking, medical, legal or pharmaceutical) preferred.
• Strong interpersonal skills, positive attitude, proactive approach to problem solving, reliable and outcome driven.
• The intern will learn current skills for file management in electronic systems. He/She will gain experience in project start, execution and completion in the pharmaceutical field that will be broadly applicable in other areas of regulated document management.
The Organization:
The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization whose mission is to develop vaccines and other biomedical innovations that prevent HIV infection. Since its founding in 1996, IAVI has provided scientific, research and development, and policy leadership to address the needs of communities and key populations at risk for HIV infection around the world. IAVI works with more than 100 academic, industry, government, civil society, clinical, and community partners in more than 25 countries. IAVI is committed to supporting the broad field of HIV vaccine research and to fostering collaborations that accelerate the development and availability of new prevention tools. In pursuit of our goals, we work to catalyze and support novel partnership models that engage partners from both the public and private sectors across the product development continuum.
IAVI’s global reach, including its clinical research network in five countries in sub-Saharan Africa and in India, has allowed IAVI to make fundamental contributions to understanding of the epidemiology, transmission, natural history, virology, and immunology of HIV infection. This work played a key role in facilitating the structure-based design of promising HIV vaccine candidates as well as the discovery of “broadly neutralizing antibodies” that are now being advanced as promising approaches for HIV prevention. IAVI’s integrated capabilities in vaccine discovery, development, and clinical research take advantage of biopharmaceutical industry expertise to accelerate the development and testing of novel HIV vaccine candidates.
In addition to its core HIV vaccine effort, IAVI is working to amplify its global health impact by working with partners to address other urgent unmet public health needs – such as vaccines for other infectious diseases – where our existing technologies, assets, and experience can add unique value.
Organizational Overview:
The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization whose mission is to translate scientific discoveries into affordable, accessible public health solutions to help the people who need them the most. Since its founding in 1996, IAVI has provided scientific, research and development, and policy leadership to address the needs of communities and key populations at risk for HIV infection around the world. IAVI works with more than 100 academic, industry, government, civil society, clinical, and community partners in more than 25 countries. IAVI is committed to supporting the broad field of HIV vaccine research and to fostering collaborations that accelerate the development and availability of new prevention tools. In pursuit of our goals, we work to catalyze and support novel partnership models that engage partners from both the public and private sectors across the product development continuum.
IAVI’s global reach, including its clinical research network in five countries in sub-Saharan Africa and in India, has allowed IAVI to make fundamental contributions to understanding of the epidemiology, transmission, natural history, virology, and immunology of HIV infection. This work played a key role in facilitating the structure-based design of promising HIV vaccine candidates as well as the discovery of “broadly neutralizing antibodies” that are now being advanced as promising approaches for HIV prevention. IAVI’s integrated capabilities in vaccine discovery, development, and clinical research take advantage of biopharmaceutical industry expertise to accelerate the development and testing of novel HIV vaccine candidates.
In addition to its core HIV vaccine effort, IAVI is working to amplify its global health impact by working with partners to address other urgent unmet public health needs – such as vaccines for other infectious diseases – where our existing technologies, assets, and experience can add unique value.
IAVI Core Values
Dedication to the Mission: We are committed to the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world to achieve a world without AIDS
Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
Collaboration: We are committed to embracing diversity, the power of glocal teamwork and the belief that by working as one we can make a difference
Leadership and Communication
Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.
All IAVI employees are expected to follow and abide by the legal, financial, regulatory, safety, and other general guidelines of IAVI, and to conduct their activities in a manner consistent with the highest personal and professional standards.
IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
