Executive Director, International Regulatory Affairs

DescriptionAt Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.Reporting to the Senior Vice President, Global Regulatory Affairs, the Executive Director, International Regulatory Affairs will lead the development and execution of regulatory strategy across Europe and Rest of World (ROW) markets, translating corporate and portfolio priorities into coordinated regulatory plans that enable development and commercialization objectives.This individual will partner with the Global Regulatory Lead on the development and execution of international regulatory strategies across all stages of product development and commercialization, ensuring alignment with corporate objectives and global regulatory requirements.The position requires deep expertise in European regulatory procedures, extensive experience interacting with international health authorities, and demonstrated leadership in developing innovative regulatory strategies for biologics and other pharmaceutical products.In close collaboration with cross-functional partners, the Executive Director integrates scientific, non-clinical, clinical, regulatory and business insights to guide and support the development of critical programs. The role ensures that development strategies are aligned with regulatory expectations and are designed to achieve successful outcomes in target global markets.This role may be located in the United States or the United Kingdom. For remote employees, travel to US headquarters for meetings may be required at the discretion of management. For those local to Waltham, MA, our office-based employees are required to work in the office three (3) days a week.Responsibilities (including, but not limited to):Develop and execute international regulatory strategies for assigned programs, ensuring alignment with overall global development and commercialization objectivesServe as the strategic partner for regulatory activities in Europe and other international marketsProvide expert guidance on regional regulatory requirements, precedents, and emerging regulatory trendsIdentify regulatory risks and opportunities and develop effective mitigation and acceleration strategiesOversee interactions with international health authorities, including EMA, national competent authorities, MHRA, Swissmedic, PMDA, NMPA, Health Canada, TGA, and other agencies as appropriateDevelop regulatory engagement strategies and oversee preparation of briefing materials and meeting packagesFacilitate agency review activities and coordinate responses to regulatory questions and requestsProvide regulatory leadership for preparation and execution of CTAs, Scientific Advice procedures, Pediatric Investigation Plans (PIPs), Marketing Authorization Applications (MAAs), and post-approval submissionsEnsure high-quality, compliant, and timely regulatory submissions across international markets.Oversee preparation of regulatory documentation supporting development and commercialization activitiesEnsure consistency and alignment between regional and global regulatory submissionsCollaborate with multidisciplinary teams, driving alignment among Clinical Development, Safety, Biostatistics, Medical Writing, Quality, and Commercial teamsCommunicate international regulatory strategy, risks, and milestones to senior management and key stakeholdersSupport portfolio planning and governance decisions through strategic regulatory inputPartner closely with International Market Access to align regulatory and reimbursement strategiesCollaborate effectively with alliance partners, consultants, and regional affiliatesMonitor evolving international regulatory requirements, guidance documents, and regulatory initiativesAssess the impact of regulatory developments on company programs and recommend appropriate actionsProvide thought leadership regarding international regulatory strategy and policyContribute to company regulatory processes, standards, and best practicesRequirementsBachelor’s degree (or equivalent) in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferredMinimum of 15+ years of increasing responsibility in Regulatory Affairs within the biopharmaceutical industry, or 12+ years of experience plus an advanced degree (e.g., PhD, PharmD, JD)Significant experience leading international regulatory strategy for biologics and/or innovative therapeuticsDemonstrated experience leading global teams through CTIS regulatory activities, including initial clinical trial applications, non-/substantial modifications, Investigational Medicinal Product Dossier updates, and regulatory interactions across EU Member StatesDemonstrated success obtaining approvals in Europe and major international marketsExtensive experience with European regulatory procedures, including MAA submissions and EMA interactionsProven track record leading regulatory activities across multiple stages of development through commercializationExperience managing complex global regulatory programs and cross-functional teamsStrong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategiesStrong oral and written communication, time management, and team-oriented leadership skills are essentialAbility to work independently, within a multi-disciplinary team, as well as with external partners and vendors.Proven mindset of proactive continuous improvementStrong attention to detailAbility to work in a fast paced-environment and to handle multiple tasksStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 25%The salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:Competitive pay and stock options for all employeesMedical, dental, and vision insurance100% Paid Parental Leave Short- and long-term disability coverageLife, Travel and AD&D401(k) Company Match with immediate company vestEmployee Stock Purchase planGenerous vacation plan and paid company holiday shutdownsVarious fertility, mental, financial, and proactive physical health programsViridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.Employee Type: FT Exempt