Associate Director, North American Regional Leader

Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements. Serve as primary point of contact for US FDA. Lead the regulatory response team for FDA and Health Canada questions. Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals. Manage routine maintenance submissions, coordinate NA post-approval commitments, provide input and review submission documents, as well as ensures approvals before dispatching to regulatory authorities. Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s). Requirements Minimum of a Bachelor's degree in scientific or equivalent discipline Bachelor's degree plus 8+ years relevant experience OR; Master's degree/ PharmD plus 6+ years relevant experience, OR; PhD plus 4+ years relevant experience Relevant regulatory experience and understanding of clinical drug development, working with US FDA and global regulatory health authorities Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions Experience in lifecycle management of IND/NDA and other regulatory submissions Demonstrated experience in critically reviewing and compiling regulatory documents is required Core Competencies Expertise in regulatory submissions and interactions with US FDA and Health Canada, with a strong background in clinical drug development and lifecycle management of IND/NDA submissions. Proven ability to develop and execute submission delivery plans while ensuring compliance with health authority requirements. Highest-signal resume keywords Regulatory Submission Strategy FDA Interaction Management IND/NDA Lifecycle Management Regulatory Document Review Clinical Drug Development ATS Optimization Keywords Hard Skills Regulatory Submission Clinical Drug Development Document CompilationSubmission Delivery Plans Regulatory Expertise Soft Skills Stakeholder Communication Team Leadership Risk Identification Certifications & Qualifications Bachelor's Degree Master's Degree PharmD PhD Industry Keywords BLA NDA IND CTA Health Authorities Regulatory Compliance #J-18808-Ljbffr Jobtailor