Senior Director, Global Regulatory Strategy

Senior Director, Global Regulatory Strategy

The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for providing strategic leadership and oversight for a therapeutic area portfolio of development and marketed products. This role is responsible for leading execution of individual products and portfolio-wide regulatory strategies that enable efficient product development, successful global registrations, and maximized asset value throughout the product lifecycle. As a member of the Global Regulatory Leadership Team, the Senior Director serves as the regulatory leader for portfolio planning, governance, and risk management activities, ensuring alignment between global regulatory strategy, development priorities, and global business objectives by driving enterprise decision-making, optimizing regulatory pathways, and proactively managing portfolio risks, while building organizational regulatory capabilities.

Key Responsibilities

• Regulatory Strategy and Portfolio Leadership
• Regulatory Submissions and Lifecycle Management
• Health Authority Interactions
• Cross-Functional and Organizational Leadership
• Compliance and Continuous Improvement

Qualifications

• Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry.
• Significant experience developing and leading global regulatory strategies across multiple development and commercial programs.
• Demonstrated success influencing portfolio-level decisions and achieving regulatory approvals in major global markets.
• Proven track record leading complex health authority interactions, negotiations, and regulatory risk-management activities.
• Experience leading and developing high-performing regulatory teams and managing organizational priorities.
• Strong understanding of portfolio governance, strategic planning, and cross-functional drug development processes.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.