Senior Manager, Regulatory Operations – FDA Submissions

Otsuka; United States; Remote; USD 135,000 - 201,000; Full time

Benefits offered by this job

Medical coverage

401(k) match

Paid time off

Job summary

Otsuka in the United States seeks a Senior Manager, LRBO Regulatory Operations to lead FDA promotional submission activities, including Form FDA 2253, OPDP presubmissions, and submission planning. You will drive process improvements, data analytics, and cross-functional collaboration, with notarial duties and potential leadership of additional resources as the function evolves.

The role requires 5+ years in pharmaceutical regulatory operations and a BA; Otsuka offers competitive benefits and a

Qualifications

• 5+ years of experience in pharmaceutical regulatory operations, including FDA promotional submissions and Form FDA 2253 requirements.
• Ability to independently manage complex operational activities and time-sensitive deliverables.
• Experience with regulatory submissions systems and related tools.

Responsibilities

• Manage FDA promotional submission activities including preparation, assembly, tracking, and submission of materials.
• Perform independent operational quality control to verify submission completeness and accuracy.
• Coordinate planning and submission to OPDP for advisory review and accelerated approval products.
• Maintain regulatory submission records in accordance with requirements.
• Develop standard submission checklists and reference materials.
• Collaborate with cross-functional stakeholders to ensure timely materials availability.
• Lead process improvements to enhance efficiency, accuracy, and scalability.

Skills

Regulatory operations

FDA submissions

Project management

Cross-functional

Notary service

Education

Bachelor's degree

Tools

Document management systems

Job description

Otsuka in the United States seeks a Senior Manager, LRBO Regulatory Operations to lead FDA promotional submission activities, including Form FDA 2253, OPDP presubmissions, and submission planning. You will drive process improvements, data analytics, and cross-functional collaboration, with notarial duties and potential leadership of additional resources as the function evolves.

The role requires 5+ years in pharmaceutical regulatory operations and a BA; Otsuka offers competitive benefits and a