Global Regulatory Strategy Lead

Otsuka America Pharmaceutical Inc.; Honolulu (HI); Remote; USD 150,000 - 224,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. in Remote is seeking a Regulatory Affairs professional to support global regulatory strategy and the planning and execution of submissions (IND, CTA, NDA/MAA) across assigned products under the Global Regulatory Lead.

The role requires translating complex global requirements and guiding project teams through regulatory challenges. You will collaborate with GRL, regional leads, and cross‑functional partners to develop regulatory plans, address health authority

Qualifications

• Experience in global regulatory submissions (IND/CTA/NDA/BLA/MAA).
• Regulatory affairs experience in pharmaceutical/healthcare industry desirable.
• RAC certification a plus.

Responsibilities

• Develop global regulatory plans and address regulatory issues and health authority queries.
• Prepare, coordinate, review, and execute submissions within timelines.
• Interact with GRL, regional leads, and cross-functional teams to ensure compliance.
• Lead internal and external staff and consultants on assigned projects.
• Monitor data and develop documentation for on-time submissions.

Skills

Regulatory strategy

Regulatory submissions

Regulatory intelligence

Team leadership

Regulatory compliance

Communication

Education

Bachelor's degree in regulatory affairs or related field

Master’s degree

Tools

EDMS

Microsoft Office

Regulatory databases

Job description

Otsuka America Pharmaceutical Inc. in Remote is seeking a Regulatory Affairs professional to support global regulatory strategy and the planning and execution of submissions (IND, CTA, NDA/MAA) across assigned products under the Global Regulatory Lead.

The role requires translating complex global requirements and guiding project teams through regulatory challenges. You will collaborate with GRL, regional leads, and cross‑functional partners to develop regulatory plans, address health authority