Senior Director, Global Regulatory Strategy & Portfolio

Otsuka America Pharmaceutical Inc.; Honolulu (HI); Remoto; USD 231.000 - 345.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive medical benefits

Generous 401(k) match

Paid time off and holidays

Tuition reimbursement

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Regulatory Strategy to lead regulatory strategy across a therapeutic portfolio, guiding development, registrations, and lifecycle management on a global scale.

As a member of the Global Regulatory Leadership Team, you will shape portfolio governance, drive risk management, and optimize regulatory pathways while mentoring junior leaders and coordinating with Clinical Development, Medical Affairs, and Commercial teams to

Competenze

• Advanced degree required; PhD, PharmD, MD or equivalent preferred.
• Minimum 15 years of progressive regulatory affairs experience in pharma/biotech.
• Proven ability to lead global regulatory strategies across multiple programs and markets.
• Demonstrated success influencing portfolio-level decisions and approvals.
• Experience leading and developing high-performing regulatory teams.

Mansioni

• Provide strategic leadership for regulatory strategy and portfolio leadership across assets.
• Oversee major global regulatory milestones (INDs, CTAs, NDAs, MAAs) and lifecycle management.
• Lead global engagement with health authorities and manage high-impact agency interactions.
• Collaborate with cross-functional teams to align regulatory strategy with development plans.

Conoscenze

Strategic leadership

Regulatory strategy

Portfolio governance

Cross-functional collaboration

Executive communication

Formazione

Advanced degree in scientific discipline

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Regulatory Strategy to lead regulatory strategy across a therapeutic portfolio, guiding development, registrations, and lifecycle management on a global scale.

As a member of the Global Regulatory Leadership Team, you will shape portfolio governance, drive risk management, and optimize regulatory pathways while mentoring junior leaders and coordinating with Clinical Development, Medical Affairs, and Commercial teams to