Senior Director, Global Regulatory Strategy

Otsuka Pharmaceutical Co., Ltd.

1d • $230,720 - $345,000

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• PhD, PharmD, MD, or equivalent preferred.

Responsibilities

• 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 organizational transformation efforts.

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
• paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree