Remote Global Regulatory Strategy Manager

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Tuition reimbursement

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed prescription drug submissions.

You will coordinate with GRL and cross-functional teams to manage lifecycle activities and ensure timely, compliant submissions. The role requires strong written and verbal communication, expertise in FDA/ICH regulations, and experience leading regulatory intelligence efforts.

Qualifications

• Bachelor's degree with 5+ years’ experience or Master's degree with 2 years’ experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry.
• Experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA).
• RAC certification a plus.

Responsibilities

• Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
• Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
• Translates complex pertinent global requirements and provides an assessment of the regulatory challenges to the GRL and the global regulatory team.
• Works collaboratively with the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
• Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.
• Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.

Skills

Regulatory strategy

Regulatory submissions

Regulatory intelligence

Leadership

Cross-functional collaboration

Written communication

Education

Bachelor's degree in regulatory affairs or related field

Master's degree in regulatory affairs or related field

Tools

Microsoft Office (Word, Excel, PowerPoint, Outlook)

Electronic Document Management Systems (EDMS)

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed prescription drug submissions.

You will coordinate with GRL and cross-functional teams to manage lifecycle activities and ensure timely, compliant submissions. The role requires strong written and verbal communication, expertise in FDA/ICH regulations, and experience leading regulatory intelligence efforts.