Senior Regulatory Operations Lead - FDA Submissions

Otsuka Pharmaceutical Co., Ltd; United States; On-site; USD 135,000 - 201,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision plans

401(k) match and retirement benefits

Paid holidays and paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager to lead LRBO regulatory operations for FDA promotional submissions, including Form FDA 2253. The role emphasizes planful submission readiness, data analytics, and process improvements.

You will collaborate across functions, oversee notarial services, and guide resources as the regulatory operations function evolves. A strong background in regulatory submissions and notary is preferred.

Qualifications

• 5+ years of relevant experience in pharmaceutical regulatory operations.
• Experience with FDA promotional submissions and Form FDA 2253 requirements.
• Ability to independently manage complex operational activities and deadlines.
• Experience evaluating and improving regulatory processes and workflows.
• Strong project management and cross-functional coordination skills.

Responsibilities

• Manage FDA promotional submission activities, including preparation and submission of materials.
• Perform independent quality control to verify submission accuracy and completeness.
• Coordinate submissions to OPDP for advisory reviews and product launches.
• Maintain submission records and develop standardized templates and checklists.
• Identify and resolve submission-related operational issues and risks.
• Collaborate with cross-functional stakeholders to ensure timely materials.

Skills

FDA submissions

Regulatory operations

Project management

Cross-functional collaboration

Process improvement

Education

Bachelor's degree

Regulatory affairs training

Notary certification (preferred)

Tools

Regulatory submissions systems

Document management platforms

Workflow technologies

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Senior Manager to lead LRBO regulatory operations for FDA promotional submissions, including Form FDA 2253. The role emphasizes planful submission readiness, data analytics, and process improvements.

You will collaborate across functions, oversee notarial services, and guide resources as the regulatory operations function evolves. A strong background in regulatory submissions and notary is preferred.