Associate Director, Global Submission Management

Role: Associate Director, Global Submission Management, overseeing global regulatory submissions for development-stage, lifecycle, regional, and post-approval programs with a focus on Pulmonary or Cell & Gene Therapy. Responsibilities: develop and maintain submission plans, ensure compliance and quality, coordinate cross-functional activities, manage risks, and lead submission teams including vendors; leverage emerging technologies like AI to enhance processes. Requirements: Bachelor's in Life Sciences, 7+ years in regulatory submission management or related fields; experience managing multiple regional submissions; proficiency with project management tools such as MS Project, Smartsheet, Veeva RIM; strong organizational and stakeholder management skills. Preferred: experience in Pulmonary or Cell & Gene Therapy. High-Value: expertise in global regulatory requirements, lifecycle submissions, cross-functional collaboration, and modern tech adoption within a biopharma context. Work setup: hybrid or on-site, with flexible work options.