[Hiring] Senior Director, Global Regulatory Strategy @Otsuka Pharmaceutical Co., Ltd.

Role Description

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 managing portfolio risks, while building organizational regulatory capabilities.

Qualifications

• 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.

Requirements

• 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.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.

Company Description

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.