Job Description

Title: Senior Manager/Associate Director, European Regulatory Liaison Location: Remote Europe Reports to: Head of European Regulatory Affairs About AlloVir AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies. We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement. Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system. Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement. At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support. The Role: As a European Regulatory Liaison, you will play a pivotal role in ensuring compliance with European regulatory requirements for our products. You will support the regulatory strategies, submissions, responses to questions and interactions with European health authorities, contributing to the successful development and commercialization of our products. Responsibilities : Support and execute regulatory strategies for product registration, approval, and post-market activities in European markets. Prepare and submit regulatory documents, including Marketing Authorization Applications (MAAs), Investigational Medicinal Product Dossiers (IMPDs), and variations. Serve as a point of contact with European health authorities (e.g., EMA, national competent authorities) for regulatory submissions and inquiries. Collaborate with cross-functional teams, including clinical, quality, and manufacturing, to ensure regulatory compliance throughout the product development and lifecycle. Provide regulatory guidance to project teams, assessing the impact of regulatory changes on product development. Monitor and interpret evolving European regulations and guidelines, ensuring the organization\'s readiness for compliance. Support regulatory intelligence efforts to keep the organization informed of upcoming regulatory changes and trends. Participate in regulatory inspections and audits, as required, and drive corrective and preventive actions. Qualifications: Bachelor\'s degree in a scientific discipline; advanced degree (Ph.D., M.S. or equivalent) preferred. At least [5] years of experience in regulatory affairs in the pharmaceutical /ATMP products. Proven track record of successful regulatory submissions and approvals in European markets. Strong knowledge of European regulatory requirements, including ATMP and clinical trial regulations. Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams. Detail-oriented, with the ability to manage multiple projects simultaneously. Regulatory affairs certification (e.g., RAC) is a plus. Why join AlloVir AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients. We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy. As part of the ElevateBio portfolio of companies, you\'ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients. Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases. At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of \'ImmUnity for all\', we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners. AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person\'s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Powered by JazzHR 4IR7YeR6Xj

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