Manager, Regulatory Operations

Otsuka Pharmaceutical Companies (U.S.)

. Coordinate high-quality and on-time regulatory publishing deliverables aligned with assigned programs/products .

Posted 9/21/2026full-timeRemote • United StatesMid-LevelSenior💰 $107,718 - $161,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory operations, including electronic submissions, compliance with health authority regulations, and effective project management. Proven ability to lead teams, innovate processes, and maintain high-quality deliverables in a collaborative environment.

Highest-signal resume keywords

Regulatory Operations ExperienceElectronic Submissions ExpertiseKnowledge of FDA, EMA, Health Canada RegulationsDocument Management Systems ProficiencyStaff Management Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory PublishingECTD FormattingDocument Quality ControlProcess MappingArchiving ActivitiesNDA/MAA ExperienceInnovative Problem Solving

Soft Skills

Written Communication SkillsOral Communication SkillsCollaboration SkillsMultitasking Ability

Tools & Technologies

DocumentumDocuBridgeInSight PublisherGlobalSubmit ValidateGlobalSubmit ReviewISIToolboxMicrosoft Office SuiteSharePoint

Certifications & Qualifications

Regulatory Affairs Professionals Society (RAPS) Certification

Industry Keywords

Regulatory Publishing DeliverablesAgency Guidance UpdatesHealth Authority ComplianceElectronic Lifecycle ManagementRegulatory Operations Work Instructions

About the role

Key responsibilities & impact

Coordinate high-quality and on-time regulatory publishing deliverables aligned with assigned programs/products
Identify impacts of agency guidance updates relevant to submission processes
Drive innovative process changes to improve efficiency
Provide regulatory publishing and submission assignments, monitoring, and oversight
Lead or support GRA efforts
Ensure assigned submissions are delivered with quality, on time, and within established budgets
Act as primary liaison coordinating regulatory publishing activities for R&D functions
Liaise with affiliates to coordinate and publish defined content
Own delivery of electronic regulatory submissions and ensure compliance with health authority requirements and established schedules
Design and implement processes and systems to maximize electronic lifecycle and maintenance submissions
Ensure submission and archival activities
Direct staff and contingent workers performing document quality-control checks and ensuring compliance with electronic regulatory standards
Oversee project team members and work assignments to vendor partners
Lead and guide Process Mapping Teams
Develop and maintain regulatory operations work instructions
Build collaborative relationships with colleagues
Organize and maintain regulatory files
Provide regulatory publishing guidance to other departments and functions

Requirements

What you’ll need

Minimum of 5 years of regulatory operations experience
In-depth first-hand experience with application electronic submissions
Knowledge of FDA, EMA, Health Canada, and Swissmedic regulations and guidance for electronic and paper submissions
Excellent knowledge and experience in regulatory operations, including formatting, publishing, submitting, lifecycling, and archiving eCTD sequences
Demonstrated performance in managing and producing time-intensive deliverables
Expert knowledge of Document Management Systems, with Documentum preferred
Experience with publishing tools such as DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox
Strong computer skills and demonstrated experience with Microsoft Office suite (Word, Excel, Access, and PowerPoint) and SharePoint
Knowledge of developing technology-leveraged processes across multiple departments/divisions
Recent experience with NDAs/MAAs is essential
Strong staff management skills
Proven ability to solve complex issues through innovative problem solving
Well-defined written and oral communication skills
Ability to work effectively in a global, matrixed, multicultural, collaborative environment
Ability to engage successfully in multiple initiatives simultaneously
Certification such as Regulatory Affairs Professionals Society (RAPS) certification preferred
Prior project management experience preferred

Benefits

Comp & perks

Incentive opportunity
Comprehensive medical coverage
Dental coverage
Vision coverage
Prescription drug coverage
Company-provided basic life insurance
Accidental death & dismemberment insurance
Short-term disability insurance
Long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs