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 manage 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.

Knowledge and Skills

• Expert knowledge of global drug development, regulatory frameworks, and registration requirements across major markets.
• Demonstrated ability to develop and execute portfolio-level regulatory strategies in a complex global environment.
• Strong business acumen with the ability to balance regulatory, scientific, operational, and commercial considerations.
• Expertise in regulatory risk assessment, scenario planning, and strategic decision-making.
• Exceptional leadership, influencing, negotiation, and stakeholder management skills.
• Proven ability to operate effectively at executive and governance levels.
• Strong people leadership capabilities, including organizational development, coaching, and talent management.
• Excellent communication and presentation skills with experience interacting with senior executives and global health authorities.
• Ability to lead through complexity, ambiguity, and organizational change while maintaining strategic focus.

Competencies

• Accountability for Results
• Strategic Thinking & Problem Solving
• Patient & Customer Centricity
• Impactful Communication
• Respectful Collaboration
• Empowered Development