Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Director, Regulatory Affairs Study Start Up (level dependent on experience) based in the United States.

The Sr. Director, Regulatory Affairs Study Start-Up will provide strategic and operational leadership for a global regulatory affairs organization supporting clinical research programs. This senior leadership role oversees organizational performance, regulatory compliance, operational delivery, financial results, and workforce development across geographically dispersed teams.

You will establish global standards, strengthen quality governance, and ensure consistent execution of study start-up activities across regions. Partnering with executive leadership, Finance, Commercial, and Clinical Operations, you will align departmental strategy with sponsor expectations and corporate objectives.

You will also drive process harmonization, technology adoption, and continuous improvement to enhance efficiency, quality, and scalability. This opportunity is suited to an experienced clinical research leader who thrives in a complex global environment and can balance strategic vision with operational accountability.