Senior Manager, LRBO Regulatory Operations

Otsuka Pharmaceutical Co., Ltd.

11d•$134,615 - $201,250

About The Position

The Senior Manager, LRBO Regulatory Operations manages and executes specialized regulatory operations activities within Laws, Regulation & Business Optimization (LRBO), primarily supporting pharmaceutical promotional regulatory activities. The role ensures 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 position provides operational expertise in submission planning and readiness, process improvement, technology optimization, data analytics, and procedural development. It 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.

Requirements

At least 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.
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 submission 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 reports.
Strong project management, organizational, and cross-functional coordination skills.
Independent judgment, proactive communication, and the 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.

Nice To Haves

Bachelor's degree in a relevant discipline preferred, or an 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.

Responsibilities

Manage and execute FDA promotional submission activities, including preparing, assembling, tracking, and submitting required materials, launch-related submission packages, and supporting documentation.
Conduct independent operational quality control to verify submission completeness, accuracy, required components, and appropriate document versions before submission.
Coordinate operational planning, preparation, and submission of materials to OPDP for advisory review, including activities related to accelerated approval products and product launches.
Maintain accurate regulatory submission records, documentation, and correspondence in accordance with applicable requirements and internal procedures.
Develop and maintain standardized submission checklists, templates, and reference materials.
Identify and resolve submission-related operational issues, escalating material risks or delays with recommended solutions.
Collaborate with cross-functional stakeholders to ensure required materials and documentation are available on time for FDA promotional submissions.
Anticipate and plan promotional submission activities, including product launches and other time-sensitive submissions, in coordination with relevant stakeholders.
Support workload planning and resource forecasting and recommend solutions to support business priorities.
Evaluate and improve operational processes to enhance efficiency, accuracy, consistency, and scalability, including standardization and automation opportunities.
Support the establishment and maintenance of business continuity and cross-training processes.
Partner with system owners and stakeholders on technology enhancements, including automation and system integration opportunities for regulatory submissions.
Develop, maintain, and analyze operational metrics, dashboards, and reports to monitor submission performance, identify trends and risks, and recommend improvements.
Provide operational updates and recommendations to functional leadership to support planning and decision-making.
Develop and maintain procedures, work practices, operational guidance, and training materials; provide related training to internal stakeholders.
Assess changes to FDA promotional submission requirements and coordinate updates to operational processes and procedures.
Serve as the primary operational point of contact for FDA promotional submission activities and coordinate cross-functional alignment on workflows, responsibilities, and operational requirements.
Support inspection, audit, and internal assessment readiness activities.
Coordinate and guide Regulatory Operations personnel and other supporting resources, as applicable, to ensure consistent execution of submission activities.
Provide notarial services and perform other regulatory, operations, legal, and/or corporate duties upon request.