Head of Regulatory Affairs

Position Description

Job Title Head of Regulatory Affairs
Location: New York, New York, preferred; US - Remote Considered, Cape Town, Africa; Remote-South Africa; Nairobi Kenya, United Kingdom - Remote; OR Amsterdam, Netherlands
Reports to: Chief Development Officer

Position Summary:

Are you an ambitious and experienced Regulatory Leader who's eager to make an impact in HIV/AIDs, TB, and other emerging infectious diseases?

IAVI is seeking a Head of Regulatory Affairs to lead and oversee IAVI's regulatory affairs strategy and operations to develop and delivery safe and effective vaccines and biologicals in these disease areas. The Head of RA leads the Regulatory Affairs Team, while serving as a core member of the Product Development Leadership Team. The Executive Director will drive the development and implementation of the regulatory strategy for each candidate product within IAVI's portfolio, ensuring compliance with all international, national, regional and local laws and regulations.

Key Responsibilities:

Regulatory Affairs Activities

• Lead and oversee technical and scientific regulatory activities in the following areas:
  • Discovery and Translational Research
  • Technology Transfer, Process and Method Development
  • Manufacturing
  • Pre-Clinical Safety
  • Clinical
  • Safety and Immunology
• Oversee the development of Regulatory Strategies to ensure the success of programs at all stages of development.
• Ensure that all regulatory submissions comply with scientific, regulatory and IAVI standards, and are written and formatted in a consistent manner.
• Develop a regulatory strategy for submission and registration for each of the products in IAVI's pipeline.
• Ensure the on-time submission of all routine regulatory submissions (e.g. Ongoing stability data, updates to Investigator Brochures, Annual Reports to Regulatory Agencies, Ethics Committees, etc.).
• Provide regulatory guidance to departments to resolve variances (e.g. Stability Failures, Clinical Holds, etc.).
• Act as a liaison to Regulatory Agencies.
• Keep abreast of changes to Global Regulations.
• Review Agreements (e.g. Master Services Agreements with CROs, CMOs, CTOs; Clinical Trial Agreements; etc.) for Regulatory Affairs and inputs required for the execution of the Agreement.
• Ensure the effective management of Agreements (e.g. Confidential Disclosure Agreements, Requests for Proposal, Consulting Agreements, Master Services Agreements, etc.) for Regulatory Affairs.

Regulatory Strategy

• In partnership with the VP, Public Health and Regulatory Science:
  • Support IAVI's internal efforts to develop new product development and regulatory science strategies to address current challenges and fill existing gaps in global health innovation.
  • Support ongoing efforts to shape scientific, public health, and regulatory policies needed to accelerate the development and implementation of IAVI's pipeline.
  • Develop and implement IAVI's global public health and regulatory science positions to accelerate global health impact.

Departmental Management Activities

• Lead the Regulatory Affairs team, establish annual goals for the group, and work with team members to achieve those goals.
• Ensure the budget for Regulatory Affairs stays on target.
• Ensure staff training on current and new regulatory requirements and maintain Professional Development Plans for all direct reports and staff.
• Track KPIs for departmental objectives and report.

Education and Work Experience:

• Advanced degree in life science or related degree is required.
• Minimum of 12 years regulatory affairs leadership experience is required.
• Regulatory Affairs Certification (RAC) preferred.

Qualifications and Skills:

• Significant experience with EMA, WHO and FDA is required.
• Demonstrated regulatory competence in all stages of vaccine development from first-in-human studies to pivotal efficacy trials and competence in generation of biologics license applications.
• Significant experience in developing and implementing novel regulatory pathways for vaccine licensure such as the FDA Animal Rule preferred.
• Significant experience working with regulatory and public health authorities in Africa and other geographies (e.g., Latin America ) relevant to IAVI's programs is preferred.
• Scientific knowledge of neglected infectious diseases, including Marburg and Sudan virus diseases, and HIV, is preferred.
• Excellent organizational skills are required.
• Excellent verbal and written communication skills are required.
• Knowledge of GMP, GLP, GCP and quality assurance and regulatory affairs associated with vaccine development 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.

Compensation and Benefits Information for US-Based Candidates:

Annual base salary for this position is: $240,000.00 - 290,000.00

Compensation And Benefits Information for NON-US Based Candidates:

Salary is paid in local currency, and is commensurate and competitive with the local labor market

Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, competitive health insurance benefits, and other benefits.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)