Director, Regulatory Affairs

Job Title: Director, Regulatory Affairs
Location: Amsterdam, Netherlands, United Kingdom- Remote Considered
Reports to: Vice President, Regulatory Affairs

Position Summary:

Ready to lead regulatory strategy for innovative products that can improve health worldwide?

As Regulatory Affairs Director, you will guide global regulatory activities for advanced-stage development programs, partnering closely with clinical, CMC, and nonclinical teams to bring critical therapies forward. From shaping regulatory strategies to ensuring successful clinical trial submissions, you'll play a key role in accelerating development and advancing IAVI's mission.

Help IAVI translate science into global health solutions – learn more and apply below!

Key Responsibilities:

• Develop regulatory strategies that allow for efficient and successful approvals of studies in multiple countries, through Phase 3 licensure studies.
• Ensure regulatory requirements and timelines are accurately tracked and communicated to project team members.
• Organize and chair meetings and communications with health authorities in targeted countries.
• Manage external resources involved in product development, including manufacturing partners, clinical trial partners, and external consultants.
• Remain up-to-date on regulatory requirements and submission documentation for countries of interest, including the European Union, the United States and multiple African countries. Ensure that the project team is aware of requirements.
• Communicate and network with scientific and regulatory colleagues to obtain and share relevant information within the organization.
• Work closely with regulatory departments/personnel at partner clinical sites to organize and plan regulatory submissions in line with country and international requirements.
• Lead the preparation of submission packages for regulatory agencies across multiple international regions in compliance with established external standards.
• Perform other tasks as assigned by the manager.

Education and Work Experience:

• Bachelor’s degree or equivalent in a relevant field (biological sciences, pharmacy). An advanced degree (MS, PhD) is desirable.
• Ten years of regulatory experience and 3 or more years biological experience relating to vaccine or bio-pharmaceutical product development – eg. manufacturing, laboratory management, preclinical safety, research.
• Experience with E.U. regulatory agencies required.

Qualifications and Skills:

• Strong expertise in preparing regulatory dossiers, leading regulator interactions, and applying regulatory requirements across Europe, and where relevant, Africa, and the U.S. for biologics, vaccines, or other biopharmaceutical products.
• Experience managing regulatory consultants, CROs, CMOs, clinical partners, or other external vendors supporting regulatory activities.
• Strong knowledge of GxP expectations, quality systems, and regulatory requirements relevant to clinical development, biologics, vaccines, and related biopharmaceutical product development.
• Ability to provide sound regulatory guidance to cross-functional project teams and external partners, reconcile differing perspectives, and influence without direct authority while preserving productive working relationships.
• Demonstrated ability to translate regulatory strategy into practical submission plans, timelines, and risk-mitigation approaches for complex programs where precedent may be limited.
• Ability to mentor or provide technical guidance to junior regulatory colleagues or cross-functional team members, as needed.
• Strong organizational skills, including the ability to manage competing priorities, meet submission timelines, and maintain clear documentation of regulatory decisions and commitments.
• Excellent written, verbal, and presentation skills, including the ability to communicate complex regulatory concepts clearly to technical and non-technical audiences.
• Ability to apply critical thinking and business judgment when using AI-generated insights, ensuring outputs are validated, practical, compliant, and appropriate for the organization’s

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:

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long-term success and global health impact
• Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
• Collaboration: We work as one IAVI team and partner with others to deliver globally accessible, urgently needed, public health solutions

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. It is IAVI’s policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disability (including physical and mental conditions unrelated to job performance), religion, creed, caste, home language, ancestry, national origin, pregnancy, marital or partnership status, sexual orientation, status as a protected veteran, ethnicity, genetic information, predisposing genetic characteristic, status as a victim of domestic violence, stalking and sex offenses, HIV status, or any other status protected by applicable federal, state, or local laws.

Compensation And Benefits Information:

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 including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on IAVI's career page.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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