IAVI: Manager of Regulatory Affairs

 Position Summary:

IAVI is seeking a qualified Manager of Regulatory Affairs who will provide support for a portfolio of vaccines and other biological products being developed for the prevention and treatment of HIV/AIDS, several emerging infectious diseases, TB, and other targets that are the focus of IAVI efforts. The successful candidate will support supports regulatory filings for studies being conducted in S. Africa and other African countries and serves as a liaison between the regulatory team at headquarters and clinical trial sites.

 Key Responsibilities:

Regulatory affairs:

  • In collaboration with senior department members, plan regulatory strategies to support the development of different products in the IAVI portfolio.
  • Maintain up-to-date knowledge on local regulatory requirements and changes to regulatory procedures and ensure that changes are communicated throughout the regulatory and clinical teams.
  • Keep abreast of changes to global regulations.
  • Organize the preparation of regulatory submissions including meeting briefing packages, CTAs, and ongoing communications to regulatory agencies as required. This will require working with project team members and clinical trial sites to write, compile, review and submit documents. Assist with other required applications such as biosafety and genetically modified product permits.
  • Compile SAHPRA Clinical Trial Applications with input from project team members.
  • Organize the preparation of all other statutory regulatory submissions e.g. Ministry of Health; Biosafety Committees.
  • Coordinate application of import permits for investigational products.
  • Review investigational product labels to ensure compliance with country regulation.
  • Track and manage the on-time submission of routine regulatory submissions such as periodic progress reporting, ongoing stability results, updates to Investigators Brochures, and responses to agency requests.
  • Assist with the development and maintenance of departmental policies, work instructions, Standard Operating Procedures, and templates used for regulatory submissions.

 Departmental and knowledge development activities:

  • Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items.
  • Remain up to date on knowledge of ICH GCP, SAHPRA-, EMA, FDA and other African countries regulations, and other local/international regulatory guidelines and requirements. Arrange for training of staff as needed.
  • Participate in training activities for new staff, as needed.
  • Identify and lead process improvement efforts. Participate in SOP writing and revisions as requested.
  • Provide status reports on metrics associated with deliverables.
  • Perform other duties as assigned by the manager.

 Education and Work Experience:

  • Bachelor’s Degree or equivalent in a life science or related subject is required; An advanced degree is desirable.
  • Minimum 5 years of experience in Regulatory Affairs with expertise and working knowledge of SAHPRA policies and procedures is required.

 Qualifications and Skills:

  • Experience working with African regulatory agencies is required.
  • Excellent track record of preparation and submission of regulatory dossiers is required.
  • Knowledge of GMP, GLP, GCP and /or quality assurance and regulatory affairs associated with biologics and vaccines is required.
  • Experience with CTA procedures and policies is required.
  • Technical/Scientific Writing and Document Formatting is required.
  • Excellent organizational skills and time management skills are required.
  • Ability to work collaboratively and proactively with staff and external partners at all levels are required.
  • Excellent verbal and written communication skills, as well as presentation skills are required.
  • Working Knowledge of Microsoft Office Applications (e.g. WORD, EXCEL, PowerPoint, Project) is required.

 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.

 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.


 




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