Senior Director, Global Regulatory Strategy & Growth

Otsuka America Pharmaceutical Inc.; Carson City (NV); Remote; USD 231,000 - 345,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to provide strategic leadership for a therapeutic area portfolio, enabling efficient development and global registrations.

As a member of the Global Regulatory Leadership Team, you will drive portfolio strategy, risk management, and senior-level interactions with health authorities to maximize asset value across the product lifecycle.

Qualifications

• Advanced degree in a scientific discipline is required; PhD, PharmD, MD, or equivalent preferred.
• 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 regulatory strategies across development, registration, commercialization, and lifecycle management.
• Oversee major global regulatory milestones including INDs, CTAs, NDAs, and MAAs.
• Lead health authority interactions and negotiations with regulatory authorities.
• Drive portfolio-level governance, risk management, and strategic decision-making.

Skills

Regulatory leadership

Strategic planning

Global regulatory strategy

Regulatory risk management

Executive communication

Cross-functional collaboration

Team development

Education

Advanced degree in science (PhD/PharmD/MD)

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Regulatory Strategy to provide strategic leadership for a therapeutic area portfolio, enabling efficient development and global registrations.

As a member of the Global Regulatory Leadership Team, you will drive portfolio strategy, risk management, and senior-level interactions with health authorities to maximize asset value across the product lifecycle.