Global Regulatory Strategy Lead

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

Benefits offered by this job

Medical, dental, vision

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Regulatory Affairs professional to develop and execute global regulatory strategies, aligning with the Global Regulatory Lead.

You will translate complex global requirements, assess regulatory challenges, and guide cross-functional teams through health authority interactions and submissions. The role focuses on planning, execution of global submissions (IND, CTAs, NDAs) and lifecycle regulatory activities, with opportunities to manage timelines,

Qualifications

• Experience in pharmaceutical regulatory affairs and global submissions.
• Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
• RAC certification a plus.

Responsibilities

• Develop global regulatory strategy and plan submissions in alignment with GRL.
• Coordinate and author regulatory submissions (INDs, CTAs, NDA/BLA) and aggregate reports.
• Provide regulatory guidance to cross-functional teams and health authorities.

Skills

Regulatory strategy

IND/CTA/NDA experience

FDA regulations

Project management

Regulatory intelligence

Education

Bachelor's degree + 5+ years regulatory affairs

Master’s degree + 2 years regulatory affairs

Job description

Otsuka America Pharmaceutical Inc. is seeking a Regulatory Affairs professional to develop and execute global regulatory strategies, aligning with the Global Regulatory Lead.

You will translate complex global requirements, assess regulatory challenges, and guide cross-functional teams through health authority interactions and submissions. The role focuses on planning, execution of global submissions (IND, CTAs, NDAs) and lifecycle regulatory activities, with opportunities to manage timelines,