Director OR Senior Director, Regulatory Affairs

Job Title: Director OR Senior Director, Regulatory Affairs

Location: Cape Town, South Africa OR Nairobi, Kenya

Reports to: Executive Director, Regulatory Affairs

Position Summary:

Are you an experienced Regulatory Affairs leader who’s eager to help bring vaccines and other cutting edge health solutions to market? Join IAVI and help us translate science into global health solutions!

IAVI is seeking an experienced a Director or Senior Director of Regulatory Affairs to serve as a regional lead for clinical trials throughout Africa. The leader will support regulatory activities to help advance products to licensure. This leader will develop and implement regulatory strategies and manage submission processes for a portfolio of products of vaccines and biologics in development to treat HIV/AIDs, TB, and other emerging infectious diseases impacting lower- & middle-income countries. The Sr. Director will also help improve and expand the capacity and infrastructure of IAVI regulatory affairs.

The Director (Or Senior) of Regulatory Affairs serves as a regional lead for IAVI sponsored clinical trials being conducted in Africa and supports regulatory activities to advance products to licensure. These trials could include different biological products being developed for the prevention and treatment of HIV/AIDS, emerging infectious diseases, TB, and other targets that are the focus of IAVI efforts. The Director develops and implements regulatory strategies and manages the submission processes for a portfolio of products. The Director also supports ongoing activities to improve and expand the capacity and infrastructure of the Regulatory Affairs department.

Key Responsibilities:

• In collaboration with the global team, the incumbent will work to identify, develop, and utilize plans needed to support both early and later phase clinical trials of HIV vaccines and other experimental vaccines and/or biologics across various disease areas.
• Engagement with regulatory agencies to gain acceptance and concurrence for trials to be conducted in Africa.
• Serve as the primary point of contact with regulatory agencies for assigned projects in scheduling and leading meetings, maintaining communication, and responding to queries for active submissions.
• Work within the project team structure to support multi-national clinical trials ensuring a harmonized approach that is aligned with the overall product development strategy.
• Manage critical issues and identify required activities to ensure that regulatory submissions are accurate and appropriate and completed with the project timeline.
• Provide leadership and management of junior regulatory team members and consultants.
• Provide training and guidance to other department members in areas of expertise.
• Perform other tasks as assigned by the Executive Director.

Education and Work Experience:

• MS or PhD in life sciences or related field is required.
• Minimum of 10 years’ experience (for Director) or minimum of 12 years’ experience for Senior Director, in regulatory affairs with related vaccine or biologics, including experience with regulatory authorities in sub-Saharan Africa.
• Experience in working with regulatory consultants and contract research organizations is required.
• Experience in working with regulatory agencies in West Africa is desirable.

Qualifications and Skills:

• Excellent organizational skills are required.
• Excellent verbal and written communication skills are required and a good working knowledge of Microsoft Office applications.
• Knowledge and experience in the preparation of regulator dossiers for regulators in Africa.
• Knowledge of GMP, GLP, GCP and /or quality assurance and regulatory affairs associated with biological products is highly desirable.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the 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. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• 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 global teamwork and the belief that by working as one we can make a difference

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. 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.

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.