South Africa Job Openings

IAVI

Manager, Regulatory Affairs

Cape Town

FULL TIME

August 28, 2024

Position Description
Job Title: Manager, Regulatory Affairs
Location: Cape Town, South Africa; South Africa - Remote; OR Nairobi, Kenya
Reports to: Senior Manager, Regulatory Affairs
Position Summary
Are you experienced in Regulatory Affairs, and eager to help translate science into global health solutions?
IAVI is seeking a Manager, Regulatory Affairs to help execute vaccine development programs, with a focus on clinical trials executed in the Africa region. The Manager, RA will partner with other functional teams to facilitate the development, preparation, and submission of clinical trial applications, and manage post-submission activities. The Manager will liaise with clinical trial sites ensuring compliance with all national regulatory authority requirements.
If you’re eager to take the next step in your regulatory career, making an impact in a mission-driven organization learn more and apply below!
Key Responsibilities:

Plan regulatory strategies in collaboration with department leadership 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, ensuring that changes are communicated throughout the regulatory and clinical teams.
Organize the preparation of regulatory submissions including meeting briefing packages, CTAs, and ongoing communications to regulatory agencies as required.
Partner 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.
Review investigational product labels to ensure compliance with country regulation.
Track and manage the timely submission of routine regulatory submissions such as periodic progress reporting, ongoing stability results, updates to Investigators Brochures, and responses to agency requests.
Contribute to departmental activities such as SOP and work instruction development and tracking and trending regulatory submission compliance.
Perform other tasks as assigned by the manager

Education and Work Experience

Bachelor’s degree or equivalent in biological sciences, pharmaceuticals, or a relevant field is required; An advanced degree is desirable.
Minimum of 5 years of experience in Regulatory Affairs with expertise and working knowledge of SAHPRA policies and procedures.
Experience with the preparation and submission of regulatory dossiers is required.
Experience working with African regulatory agencies is required.

Qualifications and Skills:

Excellent organizational skills are required.
Excellent verbal and written communication skills are required with working knowledge of Microsoft Office applications.
Knowledge of and experience with 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.
Ability to travel up to 20% of the time is required
Working Knowledge of Microsoft Office Applications (e.g. WORD, EXCEL, Power Point, 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.
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.

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