Senior Director, Global Regulatory Strategy

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic leadership and oversight for a portfolio of development and marketed products within a therapeutic area.

• Lead the execution of regulatory strategies for individual products and across the entire portfolio.

• Align the global regulatory strategy with development priorities and overarching business objectives.

• Drive planning, governance, risk management, and enterprise decision-making for the portfolio.

• Evaluate benefit-risk profiles, identify development opportunities, assess competitive landscapes, and monitor emerging regulatory trends.

• Identify and manage regulatory risks and opportunities, recommending strategies for mitigation and contingency plans.

• Oversee global regulatory milestones, including INDs, CTAs, NDAs, BLAs, MAAs, label expansions, and post-approval submissions.

• Supervise regulatory planning and execution across multiple programs to ensure timely submissions, approvals, and lifecycle deliverables.

• Review regulatory positions, critical documents, agency responses, and content for submissions.

• Drive strategies for global lifecycle management to enhance product value, expand indications, and ensure compliance.

• Establish and oversee strategies for engaging with global health authorities.

• Lead high-impact interactions with agencies, regulatory negotiations, briefing packages, and responses to complex agency inquiries.

• Act as a senior regulatory representative on portfolio governance committees, development leadership teams, and strategic planning forums.

• Collaborate with Clinical Development, Medical Affairs, Regulatory CMC, Quality, Safety, Commercial, Market Access, and Program Leadership.

• Lead, develop, and mentor Global Regulatory Leads and members of the regulatory team.

• Ensure proper resource allocation, succession planning, and capability development.

• Promote accountability, innovation, and operational excellence within the regulatory function.

• Ensure compliance with global regulations, company policies, and quality standards.

• Lead initiatives aimed at enhancing regulatory effectiveness, operational efficiency, best practices, governance, inspection readiness, and continuous improvement.

⛳️ Requirements

• An advanced degree in a scientific discipline is required; a PhD, PharmD, MD, or equivalent is preferred.

• A minimum of 15 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry is required.

• Significant experience in developing and leading global regulatory strategies across various development and commercial programs.

• Proven success in influencing portfolio-level decisions and securing regulatory approvals in major global markets.

• A demonstrated track record in leading complex interactions with health authorities, negotiations, and regulatory risk-management efforts.

• Experience in leading and developing high-performing regulatory teams while managing organizational priorities.

• A strong understanding of portfolio governance, strategic planning, and cross-functional drug development processes.

• Expert knowledge of global drug development, regulatory frameworks, and registration requirements across key markets.

• Demonstrated capability in developing and executing portfolio-level regulatory strategies in a complex global environment.

• Strong business acumen that balances 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 leadership capabilities, including organizational development, coaching, and talent management.

• Excellent communication and presentation skills with experience in interacting with senior executives and global health authorities.

• Ability to navigate complexity, ambiguity, and organizational change while maintaining a strategic focus.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-provided basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Other company-provided benefits.