Director Global Regulatory Lead

About the role

A global pharmaceutical organization is expanding its regulatory leadership team and seeking a Director, Global Regulatory Affairs to provide strategic oversight for global regulatory activities supporting one or more drug development programs. This role shapes regulatory strategy across regions, guides cross-functional teams through critical regulatory milestones, and leads effective engagement with global health authorities from development through lifecycle management. The position requires a strong balance of regulatory strategy, executional oversight, and cross-functional influence within a global, matrixed environment.

Responsibilities

• Develop and maintain integrated global regulatory strategies aligned with overall development, clinical, and commercialization objectives
• Define strategies and provide tactical guidance to teams; collaborate cross-functionally to ensure the global regulatory strategy is updated and executed
• Serve as the regulatory strategic lead for assigned programs spanning early development through late-stage development and post-approval lifecycle activities
• Lead the planning, preparation, and delivery of major global regulatory submissions, including INDs/CTAs, marketing applications, amendments, and post-approval filings
• Act as the primary regulatory interface with global health authorities, driving meeting strategy, briefing package development, responses to questions, and regulatory negotiations
• Identify regulatory risks and opportunities early; develop mitigation strategies and provide clear regulatory guidance to program teams and leadership
• Ensure regulatory strategies remain current and responsive to evolving regulatory expectations, scientific data, and business priorities
• Coordinate with regional and local regulatory partners to support timely global filings and ensure ongoing compliance across markets
• Oversee external vendors and consultants supporting regulatory activities, ensuring quality, consistency, and adherence to timelines
• Support regulatory due diligence and strategic assessments for business development, licensing, or partnering opportunities
• Contribute to broader regulatory intelligence activities and internal process improvements as needed
• Provide functional leadership and mentorship to regulatory team members and matrix partners
• Influence decision-making at the program and portfolio level through clear, data-driven regulatory perspectives
• Communicate complex regulatory concepts effectively to both technical and non-technical stakeholders
• Represent regulatory affairs in cross-functional governance forums and strategic discussions

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, MD) strongly preferred
• 8-12+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
• Experience driving global regulatory strategies for oncology indications is preferred
• Demonstrated experience developing and leading global regulatory strategies for drug development programs
• Direct experience with major health authority interactions and oversight of global regulatory submissions
• Strong understanding of global regulatory requirements and the drug development lifecycle
• Experience supporting complex or multiple concurrent development programs
• Exposure to accelerated development pathways and special regulatory designations
• Experience working across multiple global regions, including the US and international markets
• Prior experience contributing to regulatory strategy at a program or portfolio level