Senior Global Regulatory Lead, Submissions

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to develop and execute global regulatory strategy for INDs, CTAs, and marketed products. You will coordinate submissions, manage lifecycle activities, and collaborate with GRL and teams to address health authority inquiries.

Strong communication, project management, and FDA/ICH expertise are essential to drive timely approvals and ensure regulatory compliance across global programs.

Qualifications

• Experience in global regulatory submissions (IND, NDA/CTA, MAA) and strategy.
• Ability to translate global requirements and assess regulatory challenges.
• Knowledge of FDA, ICH laws, guidelines and health authority interactions.

Responsibilities

• Develops global regulatory strategy and plans for submissions.
• Identifies regulatory intelligence and assesses precedents for strategic options.
• Collaborates with GRL and cross-functional teams to address queries.
• Authors and coordinates INDs, CTAs, amendments, and reports within timelines.
• Ensures submission documents are accurate and compliant.
• Serves as sponsor point of contact to health authorities.
• Guides project teams on regulatory obligations and timelines.
• Manages internal staff and external consultants for projects.
• Interacts with internal/external units to gather data for submissions.
• Improves departmental efficiency and quality through initiatives.

Skills

Regulatory strategy

Regulatory submissions

Project management

Regulatory intelligence

Communication skills

FDA knowledge

Education

Bachelor's degree in regulatory affairs

Tools

Microsoft Office

Electronic document management systems

Job description

Otsuka America Pharmaceutical Inc. is seeking a regulatory affairs professional to develop and execute global regulatory strategy for INDs, CTAs, and marketed products. You will coordinate submissions, manage lifecycle activities, and collaborate with GRL and teams to address health authority inquiries.

Strong communication, project management, and FDA/ICH expertise are essential to drive timely approvals and ensure regulatory compliance across global programs.