Remote Global Regulatory Submissions Lead

Otsuka America Pharmaceutical Inc.; Carson City (NV); Remote; USD 150,000 - 224,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a remote Senior Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed products.

You will collaborate with GRL and cross-functional teams to plan submissions and ensure compliance with regulatory requirements. Six plus years in regulatory affairs, strong communication skills, and experience with IND/CTA/NDA submissions are highly valued.

Qualifications

• Experience in pharmaceutical/healthcare industry.
• Experience preparing global regulatory submissions (IND/CTA/NDA/BLA/MAA).
• RAC certification is a plus.

Responsibilities

• Support global regulatory strategy and planning for submissions.
• Research regulatory precedents to support strategic options.
• Coordinate with GRL and cross-functional teams on regulatory obligations.
• Prepare and manage INDs, CTAs, amendments, and reports.
• Ensure submission documents are accurate and high-quality.

Skills

Regulatory strategy

Communication skills

Project leadership

Cross-functional collaboration

Organizational skills

Microsoft Office / EDMS

Education

Bachelor’s degree with 5+ years

Master’s degree with 2 years

Tools

EDMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a remote Senior Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed products.

You will collaborate with GRL and cross-functional teams to plan submissions and ensure compliance with regulatory requirements. Six plus years in regulatory affairs, strong communication skills, and experience with IND/CTA/NDA submissions are highly valued.