Associate Director, Regulatory Project Management

Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution of complex global regulatory filings activities across the development portfolio. You will serve as a strategic partner to Regulatory Affairs leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that support successful health authority interactions and major submission milestones. You will facilitate alignment across functions, proactively identify risks and dependencies, and ensure teams remain focused on critical deliverables and timelines.

You will play a key role in advancing Regulatory Project Management best practices, supporting operational excellence initiatives, and helping to build a scalable project management framework within the Regulatory function to support the company's growing portfolio.

• Lead regulatory project management activities for assigned development programs and major regulatory submission milestones.
• Partner with Global Regulatory Leads and cross-functional functional representatives to develop integrated submission and execution plans.
• Create, maintain, and communicate comprehensive project timelines, critical path, key milestones, risks, assumptions, and dependencies.
• Facilitate cross-functional team meetings, submission working groups, and external vendor/partner interactions to drive accountability and decision-making, track commitments, and ensure execution against key submission timelines
• Monitor project progress and provide clear status reporting to regulatory leadership and key stakeholders.
• Coordinate submission readiness activities, ensuring deliverables are developed, reviewed, approved, and completed according to established timelines.
• Partner with functional representatives to manage resource needs, workload forecasting, and prioritization of critical activities.
• Drive issue resolution and escalation processes to maintain project momentum and minimize delays.
• Contribute to the development and continuous improvement of Regulatory Project Management processes, tools, templates, metrics, and governance practices.
• Bachelor's degree in life sciences or related discipline required; advanced degree preferred.
• 8-10 years of biotechnology, pharmaceutical, or related industry experience, including significant regulatory affairs, project management, or drug development experience.
• Demonstrated experience managing cross-functional projects supporting regulatory submissions and development programs.
• Knowledge of regulatory submission planning, eCTD structure, content development, and filing readiness activities.
• Ability to operate effectively in a fast-paced, highly collaborative environment with competing priorities.
• Proficiency with project management tools and systems used to support regulatory planning and execution e.g. Smartsheet, Office Timeline.

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