Senior Director, Global Regulatory Strategy

Remote

Full time

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.

• Provide strategic leadership for assets in a therapeutic area portfolio, ensuring global regulatory strategies are appropriate across development, registration, commercialization, and lifecycle management activities.
• Support with establishing an integrated regulatory vision and long-term strategy that supports portfolio objectives, optimizes development pathways, and maximizes each products value globally.
• Drive individual asset and portfolio-level regulatory decision-making by evaluating benefit-risk profiles, development opportunities, competitive landscapes, and emerging regulatory trends.
• Identify, assess, and proactively manage regulatory risks and opportunities across assets in the portfolio, recommending mitigation strategies and contingency plans.
• Ensure appropriate regulatory positions, messaging, and strategic approaches across multiple programs and regions to ensure products with the portfolio align with business objectives.
• Incorporate regulatory intelligence, health authority precedents, and evolving global requirements into portfolio strategy and investment decisions.

• Provide strategic oversight for major global regulatory milestones, including INDs, CTAs, NDAs, BLAs, MAAs, label expansions, and significant post-approval submissions.
• Ensure regulatory submission strategies support overall asset and portfolio objectives and are aligned with global development plans.
• Oversee regulatory planning and execution across multiple programs to ensure timely submissions, approvals, and lifecycle deliverables.
• Guide development of regulatory positions and review critical regulatory documents, agency responses, and submission content for strategic alignment and quality for all submissions
• Drive global lifecycle management strategies that enhance product value, expand indications, and maintain regulatory compliance.

• Establish and oversee global health authority engagement strategies across the therapeutic area portfolio.
• Lead high-impact agency interactions involving significant regulatory, scientific, or business implications.
• Serve as the senior regulatory advisor for meetings with global regulatory authorities.
• Provide strategic direction for briefing packages, regulatory negotiations, and responses to complex agency questions.
• Foster productive relationships with health authorities to facilitate successful development and registration outcomes.

• Serve as the senior regulatory representative on therapeutic area portfolio governance committees, development leadership teams, and strategic planning forums.
• Partner with Clinical Development, Medical Affairs, Regulatory CMC, Quality, Safety, Commercial, Market Access, and Program Leadership to drive integrated decision-making.
• Serve as a Global Regulatory lead as well as leading, developing, and mentoring other Global Regulatory Leads and regulatory team members, creating a high-performing and collaborative regulatory organization.
• Ensure appropriate resource allocation, succession planning, and capability development across the therapeutic area.
• Provide regulatory expertise and recommendations to support enterprise decision-making.
• Champion a culture of accountability, innovation, and operational excellence within the regulatory function.

• Ensure regulatory activities are conducted in compliance with applicable global regulations, company policies, and quality standards.
• Lead initiatives to enhance regulatory effectiveness, operational efficiency, and organizational performance.
• Drive development and implementation of regulatory best practices, standards, and governance processes.
• Promote inspection readiness and a culture of continuous improvement across the organization.
• Contribute to the evolution of the global regulatory function through strategic initiatives, process optimization, and…