Senior Manager, LRBO Regulatory Operations

Otsuka; United States; Remote; USD 135.000 - 201.000; Vollzeit

Benefits dieser Stelle

Medical coverage

401(k) match

Paid time off

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory operations

FDA submissions

Project management

Cross-functional

Notary service

Ausbildung

Bachelor's degree

Tools

Document management systems

Jobbeschreibung

Position Summary

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 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 necessary.

Company benefits

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Compensation

Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline

Application Deadline: This will be posted for a minimum of 5 business days.

EEO Statement

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

Company Description

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.