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Vp, Global Regulatory Affairs

Company: Affinivax Inc.
Location: Cambridge
Posted on: May 14, 2022

Job Description:

Title: Vice President, Global Regulatory AffairsReports to: SVP, Clinical Development and Regulatory AffairsOverviewAffinivax is a Cambridge-based clinical stage biotechnology company with a novel, next generation approach to the development of vaccines targeting infectious and immune mediated diseases. This novel vaccine technology - called Multiple Antigen Presenting System (MAPS) - enables high affinity binding of bacterial polysaccharides and proteins in a single vaccine that induces a broad and protective B-cell and T-cell immune response. The lead MAPS candidate vaccine, a 24-valent pneumococcal vaccine, received FDA Breakthrough Therapy Designation and is moving into Phase 3 clinical development.SummaryAffinivax has an exciting new opportunity for a Vice President, Global Regulatory Affairs to join our fast paced, interactive team working to develop new vaccine candidates. In this role, you will establish and manage the global regulatory strategy for the company's product pipeline and provide strategic leadership to oversee and direct all regulatory activities through early and late stage development through post-approval activities. You will be responsible for establishing a product-specific global regulatory affairs strategy aligned with business and development priorities.Your RoleLead the development of regulatory strategies designed to maximize successful and expedient global product registrations Provide regulatory guidance/expertise to cross-functional stakeholders including CMC, clinical, quality assurance, and commercial Identify key regulatory issues and proactively develop and deploy the necessary action plansLead regulatory agency interactions and represent the organization at regulatory and compliance meetings as both an expert and strategic leaderProvide oversight for submissions, including periodic update reports, to global regulatory authorities, to ensure that regulatory submissions are complete, organized, of high quality, and compliant with applicable local regulationsConduct effective and timely regulatory intelligence and research. Provide risk assessments and recommendations for various regulatory scenariosProvide guidance for managing regulatory inspections and appropriately responding to inquiries / observationsWorking with the SVP Clinical Development and Regulatory Affairs, evaluate the short and long term needs of the Regulatory Affairs organization to grow the group as needed with a focus on talent development, employee engagement and leading diversity, equity, and inclusion (DEI). QualificationsMaster's degree in a Life Sciences discipline. Advanced degree highly desirableMinimum of (10+) years of pharmaceutical regulatory affairs, including leading cross-functional project teams through regulatory milestones. Vaccine experience highly desirableExperience in all phases of global drug development from pre-IND through post-licensureSolid understanding of ICH guidance and global regulatory processesExcellent interpersonal, verbal and written communication skillsAble to work independently under tight timelines and be willing to contribute significantly to day-to-day operations as needed

Keywords: Affinivax Inc., Cambridge , Vp, Global Regulatory Affairs, Executive , Cambridge, Massachusetts

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