Chief Regulatory Officer

As a senior regulatory executive at PopVax, your role will involve overseeing the end-to-end qualification of novel vaccines and biologics in the US through FDA processes. This includes managing the entire process from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Your expertise in navigating the regulatory landscape will be crucial in ensuring successful approval and market entry for our innovative medicines. Key Responsibilities: - Lead the regulatory strategy and submission process for novel vaccines and biologics in the US, ensuring compliance with FDA requirements at every stage of development. - Collaborate with cross-functional teams to provide regulatory guidance and support, driving alignment on regulatory milestones and objectives. - Monitor and interpret regulatory developments, guidelines, and policies to inform decision-making and mitigate risks. - Interface with regulatory agencies, including the FDA, to facilitate communication and address any inquiries or requests for additional information. - Maintain up-to-date knowledge of regulatory requirements and best practices, proactively identifying opportunities for process improvements and efficiencies. Qualifications Required: - Deep expertise in regulatory affairs for vaccines and biologics, with a proven track record of successful submissions and approvals in the US market. - Familiarity with regulatory frameworks in other stringent regimes such as the EU, Canada, UK, and Japan, demonstrating the ability to navigate diverse regulatory environments. - Strong communication and interpersonal skills, enabling effective collaboration with internal and external stakeholders. - Ability to work autonomously in a fast-paced environment, demonstrating resilience and adaptability in the face of evolving challenges. - Prior experience in regulatory work for authorized COVID-19 vaccines is highly desirable and will be considered a significant advantage. At PopVax, we offer competitive compensation, comprehensive health insurance coverage for your immediate family, and a supportive work environment focused on innovation and collaboration. If you are passionate about advancing scientific and clinical frontiers in vaccines and immunotherapies, and are driven by the prospect of making a meaningful impact on global health, we invite you to join our team and be a part of our mission to save lives through groundbreaking pharmaceutical science.,