Remote Global Regulatory Strategy Manager

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

Job summary

Otsuka America Pharmaceutical Inc. seeks a Regulatory Affairs professional to lead global regulatory strategy and oversee submissions for INDs, CTAs, and other regulatory milestones.

The role collaborates with GRL and cross-functional teams to ensure timely, compliant filings and proactive regulatory planning across global programs, with travel around 20% and strong emphasis on leadership and communication.

Qualifications

• Experience working in the pharmaceutical regulatory affairs industry.
• Knowledge of preparation of global regulatory submissions (IND, CTA, NDA, NDA/BLA, MAA).
• RAC certification a plus.

Responsibilities

• Provides critical support in developing global regulatory strategy and planning of submissions in alignment with the GRL.
• Identifies regulatory intelligence and assesses regulatory challenges to support strategic options.
• Works with GRL and cross-functional teams to develop global regulatory plans and address health authority queries.
• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities (INDs, amendments, CTAs, NDs/NDAs).
• Manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within timelines.

Skills

Regulatory strategy

Regulatory submissions

Regulatory intelligence

Project leadership

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Tools

EDMS

Job description

Otsuka America Pharmaceutical Inc. seeks a Regulatory Affairs professional to lead global regulatory strategy and oversee submissions for INDs, CTAs, and other regulatory milestones.

The role collaborates with GRL and cross-functional teams to ensure timely, compliant filings and proactive regulatory planning across global programs, with travel around 20% and strong emphasis on leadership and communication.