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Senior Director, Global Regulatory Strategy
Otsuka Pharmaceutical Companies (U.S.). Provide strategic leadership and oversight for a therapeutic area portfolio of development and marketed products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and executing global regulatory strategies, managing complex health authority interactions, and leading high-performing regulatory teams. Possesses strong business acumen and a deep understanding of regulatory frameworks and drug development processes across major markets.
Highest-signal resume keywords
Global Regulatory Strategy DevelopmentRegulatory Risk ManagementHealth Authority InteractionsPortfolio GovernanceTeam Leadership and Development
ATS Keywords
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Hard Skills
Regulatory SubmissionsINDsCTAsNDAsBLAsMAAsRegulatory FrameworksDrug Development ProcessesRegulatory ComplianceRisk Assessment
Soft Skills
LeadershipInfluencingNegotiationStakeholder ManagementCommunication
Certifications & Qualifications
Advanced Degree in Scientific Discipline
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryRegulatory AffairsGlobal MarketsOperational Excellence
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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