Remote Global Regulatory Strategy Executive

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

Benefits offered by this job

Medical benefits

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy for a broad asset portfolio across development, registration, and lifecycle management.

This executive role drives global submissions and health authority interactions, aligning regulatory plans with corporate objectives. The position requires extensive experience in global regulatory leadership, demonstrated success in complex agency negotiations, and a track record of influencing

Qualifications

• Advanced degree in a scientific discipline; PhD, PharmD, MD, or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience within pharma/biotech.
• Significant experience leading global regulatory strategies across multiple programs.
• Proven track record influencing portfolio-level decisions and approvals.
• Experience leading and developing high-performing regulatory teams.

Responsibilities

• Provide strategic leadership for assets in a therapeutic area portfolio, spanning development, registration, commercialization, and lifecycle management.
• Support integrated regulatory vision and long-term strategies that optimize development pathways and portfolio value globally.
• Drive asset and portfolio-level regulatory decision-making considering benefit-risk, competition, and regulatory trends.
• Identify and mitigate regulatory risks across assets with contingency planning.
• Ensure regulatory positions and messaging align with business objectives across programs and regions.

Skills

Regulatory strategy

Portfolio leadership

Executive communication

Regulatory risk management

Cross-functional leadership

Education

Advanced degree in a scientific discipline

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy for a broad asset portfolio across development, registration, and lifecycle management.

This executive role drives global submissions and health authority interactions, aligning regulatory plans with corporate objectives. The position requires extensive experience in global regulatory leadership, demonstrated success in complex agency negotiations, and a track record of influencing