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Manager, Regulatory Compliance
Otsuka Pharmaceutical Companies (U.S.). Provide critical support for regulatory compliance activities from planning through execution .
Posted 11/11/2026full-timeRemote • United StatesMid-LevelSenior💰 $121,103 - $181,125 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance activities, including GxP compliance, audit readiness, and regulatory impact assessments. Proficient in managing cross-functional collaboration and communication while maintaining compliance metrics and documentation.
Highest-signal resume keywords
Regulatory Affairs ExperienceAudit And Inspection ExperienceKnowledge Of Drug Development ProcessStrong Oral And Written Communication SkillsProficiency In Microsoft Office Suite
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceGxP ComplianceAudit ManagementRegulatory Impact AssessmentCompliance Metrics AnalysisDocument ManagementProject ManagementKPI RecommendationsProblem SolvingSurvey Administration
Soft Skills
Organizational SkillsCommunication SkillsAbility To MultitaskRelationship BuildingInnovative Problem Solving
Tools & Technologies
Veeva VaultMonday.comElectronic Document Management SystemsGSOP SystemsOutlook
Industry Keywords
Pharmaceutical IndustryHealthcare IndustryFDA RegulationsICH GuidelinesIND ApplicationsNDA/BLA Applications
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Provide critical support for regulatory compliance activities from planning through execution
- Support SOP maintenance and GxP compliance
- Support GRA inspection and audit readiness and management activities
- Own regulatory impact assessment compliance and tracking
- Coordinate GRA-related controlled document revision cycles and ad-hoc revisions
- Work with the GSOP office to schedule KOMs, manage timelines, follow up, and support stakeholders
- Maintain knowledge and access to GSOP systems including Veeva Vault and Monday.com
- Maintain the GRA SOP revision tracker and participate in quarterly GSOP engagement meetings
- Act as GRA representative for DEAL reviews
- Lead inspection readiness activities, including inspection calendar management, functional-area presentations, KOM scheduling, notifications, document requests, audit-report review, CAPA and deviation tracking
- Collaborate with Regulatory Intelligence and Pharmacovigilance on annual RRS updates
- Participate in review and qualification of PV dashboard curated inbox notifications
- Develop and implement newsletters and compliance communications strategies
- Coordinate monthly regulatory milestone report updates with Regulatory Strategy
- Coordinate and facilitate GRA meetings and departmental events
- Maintain the GRA Collaboration Portal, contact lists, Outlook distribution lists, and organizational charts
- Analyze compliance metrics and trends, provide KPI recommendations and monthly reports, and drive corrective actions
- Prepare and maintain compliance work instructions and onboarding/offboarding materials
- Support cross-functional meetings through project reports, presentations, agendas, minutes, outcome tracking, and deliverable follow-up
- Ensure plans and activities meet timelines and escalate challenges or deviations
- Create, administer, and summarize surveys as needed
Requirements
What you’ll need- Bachelor's degree in life sciences, scientific, or engineering field
- 4+ years of general regulatory affairs experience
- Knowledge of the drug development process
- 3 years of audit and inspection experience
- Prior experience working in the pharmaceutical and/or healthcare industry (preferred)
- Prior experience with new prescription drug/biologic applications, including IND and/or NDA/BLA (preferred)
- Strong oral and written communication skills
- Working knowledge of the drug development process, laws, regulations, and guidelines including FDA and ICH
- Excellent organizational skills and ability to learn and grow
- Ability to manage and communicate issues, scopes, progress, and risks throughout the project lifecycle
- Ability to prioritize, multitask, problem solve, and work in a fast-paced environment
- Ability to establish working relationships with cross-functional teams
- Strong experience with Microsoft Word, Excel, PowerPoint, and Outlook
- Familiarity with electronic document management systems (EDMS)
- Ability to offer innovative problem-solving solutions
Benefits
Comp & perks- Incentive opportunity
- 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