Job Title

Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit OverviewThe Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and prepost regulatory approvals. The position is also responsible for oversight and execution of global regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, Designations, etc.) and regulatory compliance, including interfacing with internal and external consultants and with International Regulatory Authorities. This position would be held accountable for establishing strategic plans, policies, and procedures to ensure the company fulfills its obligations and commitment. ResponsibilitiesEstablish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team membersCommunicate regulatory strategies and plans to ensure alignment with the overall project plan and business strategyDirect and lead regulatory submissionsLead the coordination of regulatory meeting packages and attend Regulatory Authority meetingsLead the management and oversight of regulatory activities relating to clinical trials including but not limited to clinical trial applications.Assure compliance with regulatory reporting requirementsPerform other duties as requiredQualificationsBachelor's degree LifeHealth Sciences; Master's degree a plusMinimum of 10 years of experience in pharmaceutical biotechMinimum 6 years in a management role within RegulatoryComprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies, assessment of corporate risks related to regulatory and development activitiesRegulatory CMC experience a plusExcellent knowledge of regulatory, GxP, compliance, laws, and regulations for pharmaceutical productsExperience developing products, including INDs, CTAs, NDAs, MAAs, expedited approval pathways, etc.Proven ability to establish strategy and to translate it into an effective, long term action planThorough understanding of the regulatory process from development through commercializationStrong project management skillsEstablished track record with evidence of excellent project management, problem solving, collaborative, leadership, and communication skillsStrong written and oral communication skillsAble to grasp complex technical issues and make sound decisions based on data and information from various sourcesWe offer a competitive total compensation package and invite you to consider a career with Imbria!