Senior Director, Global Regulatory Strategy

🕒 September 22

🇺🇸 United States – Remote

💵 $230.7k - $345k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 2%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Provide strategic leadership and oversight for a therapeutic area portfolio of development and marketed products • Lead execution of individual product and portfolio-wide regulatory strategies • Align global regulatory strategy with development priorities and global business objectives • Drive portfolio planning, governance, risk management, and enterprise decision-making • Evaluate benefit-risk profiles, development opportunities, competitive landscapes, and emerging regulatory trends • Identify and manage regulatory risks and opportunities, recommending mitigation strategies and contingency plans • Oversee global regulatory milestones including INDs, CTAs, NDAs, BLAs, MAAs, label expansions, and post-approval submissions • Oversee regulatory planning and execution across multiple programs to ensure timely submissions, approvals, and lifecycle deliverables • Review regulatory positions, critical documents, agency responses, and submission content • Drive global lifecycle management strategies to enhance product value, expand indications, and maintain compliance • Establish and oversee global health authority engagement strategies • Lead high-impact agency interactions, regulatory negotiations, briefing packages, and responses to complex agency questions • Serve as senior regulatory representative on 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 • Lead, develop, and mentor Global Regulatory Leads and regulatory team members • Ensure resource allocation, succession planning, and capability development • Champion accountability, innovation, and operational excellence within the regulatory function • Ensure compliance with global regulations, company policies, and quality standards • Lead initiatives for regulatory effectiveness, operational efficiency, best practices, governance, inspection readiness, and continuous improvement

🎯 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 balancing 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

🏖️ 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) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits

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