Global Regulatory Strategy Director, Portfolio Leadership

Otsuka America Pharmaceutical Inc.; Dover (DE); Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Remote work flexibility

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Regulatory Strategy to provide strategic regulatory leadership across a broad portfolio. The role drives global planning, lifecycle management, and high-impact agency interactions to maximize asset value.

You will partner with clinical development, medical affairs, and commercial leaders to align regulatory strategy with business objectives, while ensuring compliance and operational excellence.

Qualifications

• Advanced degree in a scientific discipline required; PhD, PharmD, MD, or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience in pharma/biotech.
• Proven track record leading global regulatory strategies and major submissions.

Responsibilities

• Provide strategic leadership for global regulatory strategy across development and lifecycle.
• Lead portfolio governance, risk management, and regulatory decision-making.
• Oversee major submissions: INDs, NDAs, BLAs, MAAs, and label expansions.
• Drive health authority interactions and strategic guidance for complex questions.
• Mentor and develop senior regulatory talent and cross-functional teams.

Skills

Regulatory strategy

Global regulatory knowledge

Executive leadership

Cross-functional collaboration

Risk management

Strategic planning

Regulatory submissions

Education

PhD/PharmD/MD preferred

Tools

Regulatory databases

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Regulatory Strategy to provide strategic regulatory leadership across a broad portfolio. The role drives global planning, lifecycle management, and high-impact agency interactions to maximize asset value.

You will partner with clinical development, medical affairs, and commercial leaders to align regulatory strategy with business objectives, while ensuring compliance and operational excellence.