We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical products. This role partners cross-functionally with R&D, Clinical, Quality, and Commercial teams to ensure regulatory alignment with business objectives and compliance with global health authority requirements. The Associate Director provides expert guidance on regulatory pathways, risk assessment, and submission strategies.Key ResponsibilitiesRegulatory Strategy (50%)Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage.Provide solid regulatory solutions and guidance to the cross-functional teams and senior management.Provide tactical support and operational expertise with “hands on” support as needed.Project Management (25%)Assess project plans and timelines.Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time.Regulatory Compliance (25%)Ensure compliance of regulatory strategies and submissions.Oversee preparation and review of regulatory submissions and responses.Monitor regulatory trends and ensure proactive strategy adjustments.Other duties and responsibilities as assigned.
