Global Regulatory Strategy Director — Remote

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

Benefits offered by this job

Comprehensive medical

Dental insurance

Vision insurance

Prescription drug coverage

Life insurance

AD&D

Short-term disability

Long-term disability

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Regulatory Strategy to provide strategic leadership for a therapeutic portfolio across development and commercialization.

You will guide regulatory pathways and steward lifecycle management while aligning with enterprise objectives. As part of the Global Regulatory Leadership Team, you will manage regulatory risk, mentor teams, and collaborate with Clinical Development, Medical Affairs, Quality, and Commercial to optimize

Qualifications

• Advanced degree in a scientific discipline; PhD/PharmD/MD or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience in the pharmaceutical/biotechnology industry.
• Experience leading global regulatory strategies across multiple development and commercial programs.
• Proven track record influencing portfolio decisions and achieving regulatory approvals.

Responsibilities

• Provide strategic leadership for global regulatory strategy and portfolio governance.
• Oversee major regulatory submissions (INDs, CTAs, NDAs, MAAs) and lifecycle management.
• Lead health authority interactions and negotiations at senior levels.
• Mentor and develop Global Regulatory Leads and teams.
• Ensure regulatory activities comply with global standards and drive continuous improvement.

Skills

Regulatory strategy leadership

Global regulatory experience

Portfolio governance

Cross-functional leadership

Executive communication

Education

Advanced degree in scientific discipline

PhD/PharmD/MD preferred

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Regulatory Strategy to provide strategic leadership for a therapeutic portfolio across development and commercialization.

You will guide regulatory pathways and steward lifecycle management while aligning with enterprise objectives. As part of the Global Regulatory Leadership Team, you will manage regulatory risk, mentor teams, and collaborate with Clinical Development, Medical Affairs, Quality, and Commercial to optimize