[Hiring] Director, Regulatory Affairs @IAVI

Role Description

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.

• 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.

Qualifications

• 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.

Requirements

• 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 needs.

Benefits

• Salary is paid in local currency, and is commensurate and competitive with the local labor market.
• 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.
• Other benefits as detailed on IAVI's career page.