[Hiring] Senior Manager, Regulatory Operations @Otsuka Pharmaceutical Co., Ltd.

Role Description

The Senior Manager, LRBO Regulatory Operations is responsible for managing and executing specialized regulatory operations activities within Laws, Regulation & Business Optimization (LRBO), primarily supporting pharmaceutical promotional regulatory activities. The position ensures the accurate, timely, and compliant preparation and submission of promotional materials to the U.S. Food and Drug Administration (FDA), including Form FDA 2253 submissions and applicable Office of Prescription Drug Promotion (OPDP) presubmissions.

The incumbent provides operational expertise in submission planning and readiness, process improvement, technology optimization, data analytics, and procedural development. The position requires independent judgment, proactive problem-solving, and cross-functional collaboration to support efficient, effective, and scalable regulatory operations. The incumbent also provides notarial services and may coordinate or oversee additional Regulatory Operations resources as the function evolves.

Qualifications

• 5+ years of relevant experience in pharmaceutical regulatory operations, including experience with FDA promotional submissions and Form FDA 2253 requirements.
• Knowledge of FDA promotional submission requirements and applicable OPDP presubmission processes.
• Demonstrated ability to independently manage complex operational activities, competing priorities, and time-sensitive deliverables.
• Experience evaluating operational processes, identifying improvement opportunities, and implementing effective solutions.
• Experience with regulatory submissions systems, document management platforms, workflow technologies, and related operational tools.
• Strong analytical and problem-solving skills, including the ability to develop and interpret operational metrics, dashboards, and reporting.
• Strong project management, organizational, and cross-functional coordination skills.
• Demonstrated independent judgment, proactive communication, and ability to develop actionable recommendations.
• Ability to lead projects, coordinate resources, and provide guidance or oversight to others.
• Strong written and verbal communication skills, including the ability to communicate effectively with senior stakeholders.
• Active Notary Public commission in the applicable jurisdiction, or ability to obtain a commission within six months of appointment; must maintain a valid commission thereafter.

Requirements

• Bachelor's degree in a relevant discipline preferred, or equivalent combination of education, training, and relevant professional experience.
• Additional training or certification in regulatory affairs, regulatory operations, project management, or related disciplines preferred.
• Paralegal certification and notary public commission preferred.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.