Global Regulatory Strategy Director — Leader (Remote)

Otsuka America Pharmaceutical Inc.; Salt Lake City (UT); Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive benefits package

Great Place to Work certified

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to provide strategic leadership for its therapeutic portfolio, guiding development, registrations, and lifecycle approaches on a global scale.

The role reports to the Global Regulatory Leadership Team, overseeing portfolio planning, risk management, and interdepartmental collaboration to maximize asset value across markets and ensure compliant, timely submissions.

Qualifications

• Advanced degree in a scientific discipline; PhD/PharmD/MD preferred.
• Minimum 15 years of progressive regulatory affairs experience in pharma/biotech.
• Proven success leading global regulatory strategies across multiple programs.
• Experience guiding health authority negotiations and complex approvals.

Responsibilities

• Provide strategic leadership for global regulatory strategy across development, registration, and lifecycle management.
• Lead portfolio governance and risk management to align with business objectives.
• Oversee global submissions and lifecycle activities across programs.
• Mentor regulatory teams and develop organizational capabilities.
• Engage with health authorities for strategic discussions.

Skills

Strategic leadership

Regulatory strategy

Cross-functional leadership

Executive communication

Education

Advanced degree in a scientific discipline

PhD/PharmD/MD or equivalent preferred

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to provide strategic leadership for its therapeutic portfolio, guiding development, registrations, and lifecycle approaches on a global scale.

The role reports to the Global Regulatory Leadership Team, overseeing portfolio planning, risk management, and interdepartmental collaboration to maximize asset value across markets and ensure compliant, timely submissions.