Executive Director of Regulatory Affairs

Executive Director, Regulatory AffairsThis position is responsible for overseeing clinical regulatory activities and submissions across the organization’s full development portfolio. This role delivers global strategic leadership for clinical regulatory efforts tied to assigned programs, ensuring adherence to regulatory standards while maintaining excellence in documentation, compliance, and reporting.Core ResponsibilitiesPartner to shape and execute regulatory strategies, fostering strong and credible relationships with health authorities worldwide.Direct the planning, development, and implementation of clinical regulatory strategies and submissions across multiple programs.Act as a key liaison to regulatory agencies, including the FDA and international authorities, clearly representing organizational positions.Lead the preparation, review, and timely submission of regulatory documents in alignment with global requirements and internal quality standards.Analyze and interpret evolving regulatory guidelines, translating them into internal policies, procedures, and compliance frameworks.Collaborate cross-functionally to support regulatory deliverables and ensure consistency and quality across submissions.Oversee external partners, including vendors and consultants, contributing to regulatory activities.Strengthen and maintain regulatory infrastructure and operational processes, including:Electronic document management systemsRegulatory publishing platformsStandardized templates and documentation practicesSOP development, maintenance, and governanceContribute to regulatory risk management and serve as a delegate for the VP of Regulatory Affairs when required.Monitor and manage project budgets, timelines, and resource allocation.Qualifications & ExperienceExtensive experience spanning all stages of drug development, from early development through post-marketing activities.In-depth knowledge of U.S. regulatory requirements, along with a solid understanding of global regulatory environments.Proven track record leading major regulatory submissions, including: IND and CTA applications ; NDA, BLA, and MAA filingsExperience with at least one successful registration submission is preferredDemonstrated experience managing key regulatory interactions, such as: FDA meetings (e.g., Pre-NDA, End-of-Phase 2)Strong familiarity with international clinical trial regulations, particularly in regions such as: European Union, United Kingdom, Canada, Australia, and Asia-PacificExperience supporting regulatory strategy through product approval and lifecycle management.Ability to develop high-quality regulatory documentation and effectively respond to agency inquiries.