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Remote

Full time

R13191

Position Summary

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.

Essential Duties and Responsibilities

Promotional Regulatory Submission Operations

+ Manage and execute FDA promotional submission activities, including preparation, assembly, tracking, and submission of required materials, as well as launch-related submission packages and supporting documentation.

+ Perform independent operational quality control to verify submission completeness, accuracy, required components, and appropriate document versions prior to submission.

+ Coordinate the operational planning, preparation, and submission of materials to OPDP for advisory review, including activities associated with 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 to support accuracy, consistency, and timely execution.

+ Identify and resolve submission-related operational issues, proactively escalating material risks or delays with recommended solutions.

+ Collaborate with relevant cross-functional stakeholders to ensure timely availability of required materials and documentation for FDA promotional submissions.

Operational Planning and Process Improvement

+ Anticipate and plan for promotional submission activities, including product launches and other time-sensitive regulatory submissions, and coordination with relevant stakeholders.

+ Support workload planning and o resource forecasting needs and recommending solutions to support business priorities.

+ Evaluate and improve operational processes to enhance efficiency, accuracy, consistency, and scalability, including opportunities for standardization and automation.

+ Support with establishing and maintaining business continuity and cross-training processes to ensure consistent regulatory submission support and reduce reliance on individual resources.

Systems, Technology, and Data Analytics

+ Partner with system owners and relevant stakeholders to contribute to technology enhancements, including automation and system integration opportunities, supporting regulatory submission activities.

+ 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.

Operational Governance and Cross-Functional Support

+ Develop and maintain applicable procedures, work practices, operational guidance, and training materials; provide related training to internal stakeholders.

+ Assess changes to FDA promotional submission requirements and coordinate necessary updates to operational processes and procedures.

+ Serve as primary operational point of contact for FDA promotional submission activities, coordinating cross-functional alignment on workflows, responsibilities, and operational requirements.

+ Support applicable inspection, audit, and internal assessment readiness activities.

+ Coordinate and provide guidance to Regulatory Operations personnel and other supporting resources, as applicable, to ensure consistent execution of submission activities.

+ Perform other regulatory, operations, legal, and/or corporate duties upon request.

Knowledge, Skills, Competencies, Education, and Experience

Knowledge/Experience and Skills

+ 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.

Educational Qualification

+ 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.

Physical Demands and Work Environment

+ Type/keyboard, stand, lift/carry/pull light Items (10 lbs.).

+ Use computer, phone, copier.

+ Occasional travel may be required.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as ...

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