Associate Director, Strategy Lead for Submission Automation

What you'll do

• Develop and execute the business strategy and roadmap for report automation supporting dossier submissions like INDs and BLAs.
• Identify opportunities to standardize and modernize submission-related reporting through automated systems.
• Translate complex business requirements into practical, scalable technical specifications for IT and delivery teams.
• Serve as a bridge between business process owners and technical teams to ensure alignment on priorities and execution.
• Develop business cases and strategic recommendations for investments in automation technologies.
• Lead cross-functional alignment across Development Sciences, Regulatory Affairs, and dossier management teams.
• Facilitate prioritization, decision-making, and issue resolution across multiple stakeholders and workstreams.
• Communicate roadmap progress, risks, and strategic recommendations clearly to senior leadership.

What we're looking for

• Bachelor's Degree with 9 years’ experience, Master's Degree with 8 years’ experience, or PhD with 4 years’ experience.
• Significant experience in strategy, business process enablement, program leadership, or digital/data initiatives in a regulated environment.
• Demonstrated ability to build roadmaps and lead cross-functional initiatives involving business and technology stakeholders.
• Proven ability to work effectively across matrixed organizations and influence stakeholders at multiple levels.
• Strong communication, facilitation, and stakeholder management skills.
• Knowledge of data, reporting, automation, and governance concepts relevant to regulated business processes (preferred).
• Experience working with submission processes, dossier-related activities, regulatory documentation, or report automation (preferred).
• Experience partnering with technical teams to shape requirements and support delivery of business-focused solutions (preferred).