Remote: Global Regulatory Strategy Director
Otsuka America Pharmaceutical Inc.
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Benefits offered by this job
Job summary
Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Regulatory Strategy to lead portfolio-wide regulatory strategy, ensure successful global registrations, and optimize asset value across the product lifecycle.
You will guide regulatory planning, risk management, and agency engagement at the enterprise level. You will collaborate with cross-functional leaders to align development plans with regulatory requirements, drive strategic decisions, and mentor the regulatory team
Qualifications
- Advanced degree in a scientific field (PhD/PharmD/MD preferred).
- 15+ years regulatory affairs experience in pharma/biotech.
- Proven track record leading global regulatory strategies across programs.
- Experience influencing portfolio decisions and achieving approvals.
- Leadership of high-performing regulatory teams across regions.
Responsibilities
- Provide strategic leadership for global regulatory strategy and portfolio governance.
- Oversee regulatory submissions milestones (INDs, CTAs, NDAs, MAAs) and lifecycle management.
- Lead health authority interactions with senior stakeholders.
- Collaborate with Clinical Development, Medical Affairs, CMC, Quality, and Commercial teams.
- Drive compliance, process improvements, and governance across the regulatory function.
Skills
Education
Job description
Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Regulatory Strategy to lead portfolio-wide regulatory strategy, ensure successful global registrations, and optimize asset value across the product lifecycle.
You will guide regulatory planning, risk management, and agency engagement at the enterprise level. You will collaborate with cross-functional leaders to align development plans with regulatory requirements, drive strategic decisions, and mentor the regulatory team
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