Remote Global Regulatory Strategy Manager

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Affairs professional to support global regulatory strategy, planning and execution of submissions for INDs, CTAs, NDAs and related reports.

You will collaborate with GRL, regional leads and cross-functional teams to ensure timely, compliant documentation and communications with health authorities. The role requires 5+ years in regulatory affairs within pharma/healthcare, strong writing and project management skills, and

Qualifications

• Experience in regulatory affairs within pharma/healthcare.
• Knowledge of global regulatory submissions (IND, CTA, NDA, BLA, MAA).
• RAC certification is a plus.

Responsibilities

• Support global regulatory strategy and planning for submissions.
• Coordinate regulatory intelligence to inform strategic options.
• Develop regulatory plans with GRL and cross-functional teams.
• Prepare INDs, CTAs, amendments, supplements, and reports on time.

Skills

Communication

Regulatory knowledge

Regulatory intelligence

Leadership

Cross-functional collaboration

Education

Regulatory affairs degree

Tools

Microsoft Office

EDMS

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Affairs professional to support global regulatory strategy, planning and execution of submissions for INDs, CTAs, NDAs and related reports.

You will collaborate with GRL, regional leads and cross-functional teams to ensure timely, compliant documentation and communications with health authorities. The role requires 5+ years in regulatory affairs within pharma/healthcare, strong writing and project management skills, and