Associate Director, Project Manager - Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Project Manager - Regulatory Affairs based in United States. This is a strategic regulatory project management leadership role supporting global development programs in the rare disease space. You will coordinate complex regulatory activities across multiple functions, ensuring submissions, milestones, and commitments remain aligned with program strategy. The role combines hands-on project management with cross-functional leadership and executive visibility. You will work closely with Regulatory Affairs, Clinical, CMC, Quality, Medical Writing, Operations, and external partners. A key focus will be building scalable timelines, dashboards, processes, and governance practices that improve regulatory execution. The position offers the opportunity to influence how global regulatory programs are planned, monitored, and delivered. You’ll join a collaborative, fast-paced environment where your work directly contributes to advancing therapies for patients with significant unmet needs. Lead regulatory project management activities across one or more global development programs, ensuring regulatory plans, timelines, deliverables, and submission activities align with program strategy and organizational priorities. Partner with Regulatory Leads to coordinate global regulatory team meetings, including agendas, decisions, documentation, action tracking, and follow-up on commitments. Develop and maintain integrated regulatory project plans and timelines covering health authority milestones, cross-functional dependencies, submission deliverables, and key program decisions. Plan and track major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, health authority responses, and other regulatory deliverables. Coordinate with Regulatory Operations, Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing, Quality, Commercial teams, and external vendors to ensure timely and high-quality execution. Support submission readiness by coordinating content plans, document ownership, review cycles, submission timelines, and regulatory information management activities. Create dashboards, milestone trackers, and status reports that provide leadership and program teams with clear visibility into progress, risks, dependencies, and upcoming deliverables. Identify and communicate regulatory project risks, resource constraints, timeline challenges, and cross-functional dependencies, helping teams develop mitigation strategies. Coordinate preparation for health authority interactions, advisory committees, inspections, audits, and regulatory responses, including timelines, materials, contributors, and follow-up actions. Drive continuous improvement of regulatory project management processes, tools, templates, meeting practices, dashboards, and operating models to increase consistency and scalability. Maintain accurate regulatory project documentation, including decisions, action items, submission plans, timelines, and key deliverables within designated systems and repositories. Provide leadership, mentoring, and guidance to regulatory project management colleagues and cross-functional partners, with potential responsibility for direct reports or resource planning as the function develops. Requirements: Bachelor’s degree in Life Sciences or a related discipline is required; a Master’s degree, PharmD, or PhD is preferred. Equivalent combinations of education and relevant professional experience may be considered. 8+ years of project management experience within the biotechnology or pharmaceutical industry, with regulatory project management experience strongly preferred. Strong understanding of global regulatory affairs, submission requirements, compliance processes, and the development of therapies for ra