Global Regulatory Strategy Leader

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 231,000 - 345,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Companies (U.S.) seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy for a therapeutic-area portfolio of development and marketed products. The role drives efficient development, global registrations, and lifecycle value across programs, reporting to the Global Regulatory Leadership Team.

The position requires extensive experience shaping regulatory strategy, managing multi-program portfolios, and leading global health authority interactions.

Qualifications

• Minimum 15 years of progressive regulatory affairs experience.
• Experience leading global regulatory strategies across multiple development and commercial programs.
• Proven track record influencing portfolio decisions and achieving regulatory approvals.
• Experience leading and developing high-performing regulatory teams.
• Strong governance, strategic planning, and cross-functional collaboration.

Responsibilities

• Provide strategic leadership for assets across development, registration, commercialization, and lifecycle management.
• Oversee major global regulatory milestones and submission planning.
• Lead health authority engagements, negotiations, and regulatory risk management.
• Ensure alignment of regulatory strategy with global development plans and business objectives.
• Mentor and develop regulatory leads and teams to high performance.

Education

Advanced degree in scientific discipline

PhD/PharmD/MD preferred

Job description

Otsuka Pharmaceutical Companies (U.S.) seeks a Senior Director, Global Regulatory Strategy to lead regulatory strategy for a therapeutic-area portfolio of development and marketed products. The role drives efficient development, global registrations, and lifecycle value across programs, reporting to the Global Regulatory Leadership Team.

The position requires extensive experience shaping regulatory strategy, managing multi-program portfolios, and leading global health authority interactions.