Senior Manager, LRBO Regulatory Operations

Otsuka Pharmaceutical Companies (U.S.)

. Manage and execute FDA promotional submission activities, including preparation, assembly, tracking, and submission of required materials .

Posted 10/30/2026full-timeRemote • United StatesSenior💰 $134,615 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing FDA promotional submission activities, including preparation and tracking of submission materials, while ensuring compliance with regulatory requirements. Proficient in operational quality control, process improvement, and cross-functional collaboration to support timely and accurate submissions.

Highest-signal resume keywords

FDA Promotional SubmissionsRegulatory OperationsOperational Quality ControlProject ManagementAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submissions SystemsDocument Management PlatformsWorkflow TechnologiesOperational Metrics DevelopmentSubmission ChecklistsSubmission Packages PreparationOperational Guidance DevelopmentTraining Materials DevelopmentProcess ImprovementAutomation Opportunities

Soft Skills

Problem-Solving SkillsProactive CommunicationCross-Functional CoordinationOrganizational SkillsIndependent Judgment

Certifications & Qualifications

Active Notary Public CommissionParalegal CertificationRegulatory Affairs CertificationProject Management Certification

Industry Keywords

FDAForm FDA 2253OPDPPromotional Submission RequirementsRegulatory CompliancePharmaceutical Regulatory OperationsBusiness ContinuityInspection ReadinessAudit ReadinessOperational Processes

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Manage and execute FDA promotional submission activities, including preparation, assembly, tracking, and submission of required materials
Prepare launch-related submission packages and supporting documentation
Perform independent operational quality control for submission completeness, accuracy, required components, and document versions
Coordinate planning, preparation, and submission of materials to OPDP for advisory review
Maintain regulatory submission records, documentation, and correspondence
Develop and maintain submission checklists, templates, and reference materials
Identify and resolve submission-related operational issues and escalate material risks or delays with recommended solutions
Collaborate with cross-functional stakeholders to ensure timely availability of submission materials
Plan promotional submissions, product launches, and other time-sensitive regulatory submissions
Support workload planning and resource forecasting
Evaluate and improve operational processes, including standardization and automation opportunities
Establish and maintain business continuity and cross-training processes
Contribute to technology enhancements, automation, and system integration opportunities
Develop, maintain, and analyze operational metrics, dashboards, and reports
Provide operational updates and recommendations to functional leadership
Develop and maintain procedures, work practices, operational guidance, and training materials
Provide training to internal stakeholders
Assess changes to FDA promotional submission requirements and update processes and procedures
Serve as primary operational point of contact for FDA promotional submission activities
Support inspection, audit, and internal assessment readiness
Coordinate and guide Regulatory Operations personnel and supporting resources
Perform other regulatory, operations, legal, and/or corporate duties as requested

Requirements

What you’ll need

5+ years of relevant experience in pharmaceutical regulatory operations, including 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 submissions systems, document management platforms, workflow technologies, and related operational tools
Strong analytical and problem-solving skills, including developing and interpreting operational metrics, dashboards, and reporting
Strong project management, organizational, and cross-functional coordination skills
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 communication 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
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
Ability to type/keyboard, stand, and lift/carry/pull light items (10 lbs.)
Ability to use a computer, phone, and copier

Benefits

Comp & perks

Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company-provided benefits
Occasional travel may be required