Senior Director, Regulatory Affairs

Senior Director Of Regulatory AffairsIf you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix Therapeutics. The culture at CorMedix Therapeutics is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare.CorMedix Therapeutic's greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose. We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN (minocycline), REZZAYO (rezafungin), VABOMERE (meropenem and vaborbactam), ORBACTIV (oritavancin), BAXDELA (delafloxacin), and KIMYRSA (oritavancin), as well as TOPROL-XL (metoprolol succinate).CorMedix Therapeutics has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal disease (IFD) in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026.The Senior Director of Regulatory Affairs provides strategic leadership and formulates comprehensive regulatory strategies for product development and life cycle management of approved products, ensuring ongoing compliance with applicable regulatory requirements. This role is pivotal in facilitating proactive and effective interactions with regulatory bodies to secure timely and favorable regulatory decisions.ResponsibilitiesProvides high-level strategic leadership and direction for regulatory activities, including submission preparation, defense, and interactions with regulatory authorities for new and ongoing clinical and surveillance programs, including labeling negotiationsOversees and interprets regulations, guidelines, procedures, and policies related to the development and global registration of drug products, with a specific focus on clinical development and global registrationLeads and advises regulatory and clinical teams, providing expert guidance to clinical CROs, regulatory vendors, and area authors/reviewers on submission and dossier requirementsActs as the primary point of contact with regulatory authorities, fostering strong working relationships with internal clinical team partners, project consultants and contractors, and external CROsDevelops and implements comprehensive regulatory strategies and operations, ensuring timely delivery of all regulatory submissionsCreates and executes detailed regulatory submission project and resource plans, sets goals, and tracks progress towards critical milestones for major regulatory submissionsProvides regulatory insights and input into new business venture activities, contributing to strategic decision-makingEffectively addresses and resolves regulatory authority and business partner questions and concerns, ensuring compliance and alignment with business objectivesMay have oversight of 1-2 Regulatory affairs personnelEducationBachelor's degree or equivalent in life sciences or related disciplineQualificationsFull lifecycle experience from early development to managing marketed productsStrong project management and computer skills (including Microsoft office)Demonstrated strong leadership and management skills; proven ability to work with very little guidance/supervision with a proactive approachGlobal regulatory management experienceExperience with Post Marketing Requirement and PREA commitmentsKnowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicinesHighly collaborative and works with ease in matrix environmentMinimum of 10 years pharmaceutical experience and 8 years regulatory experience in in drug development and registration activitiesPosition TypeFull TimeLocation / TravelNew Jersey home office preferred (Hybrid), with travel as required