Senior Regulatory Affairs Associate – Regulatory Compliance

Parexel

. Function as SOP Coordinator for Global Regulatory Affairs controlled document revision cycles and ad-hoc revisions .

Posted 10/5/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs with a strong understanding of the drug development process, compliance requirements, and document management systems. Proficient in coordinating cross-functional teams and managing timelines to ensure inspection readiness and regulatory compliance.

Highest-signal resume keywords

Regulatory Affairs ExperienceDocument Management SystemsAudit And Inspection ExposureStrong Communication SkillsMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceDocument Revision ManagementKPI ReportingSOP DevelopmentPharmacovigilance KnowledgeInspection ReadinessProject ManagementSurvey AdministrationCompliance Performance MetricsDrug Development Process Knowledge

Soft Skills

Problem-SolvingMulti-TaskingCollaborationTime ManagementCommunication

Tools & Technologies

Veeva VaultMonday.comMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookElectronic Document Management Systems

Industry Keywords

FDA RegulationsICH GuidelinesPharmaceutical IndustryRegulated EnvironmentNew Prescription Drug ApplicationsBiologic Applications

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Function as SOP Coordinator for Global Regulatory Affairs controlled document revision cycles and ad-hoc revisions
Schedule Kick-Off Meetings, manage timelines, support document revisions, and maintain the GRA SOP revision tracker
Maintain knowledge and access to GSOP systems such as Veeva Vault and Monday.com
Support inspection readiness, including inspection calendar management, presentations, notifications, document requests, audit reports, CAPAs, and Deviations
Collaborate with Regulatory Intelligence and Pharmacovigilance teams on annual Regulatory Requirements Summary updates
Review and qualify Pharmacovigilance dashboard curated inbox notifications
Develop and distribute newsletters and compliance communications
Coordinate monthly regulatory milestone report updates with Regulatory Strategy
Coordinate and facilitate GRA staff, steering group, and departmental meetings
Maintain the GRA Collaboration Portal, contact lists, Outlook distribution lists, and organizational charts
Prepare KPI reports, including training metrics, and publish results on the GRA Collaboration Portal
Prepare and maintain compliance work instructions, SOP revisions, milestone reviews, and onboarding/offboarding materials
Provide meeting support, project reports, presentation materials, agendas, minutes, and follow-up on deliverables
Ensure activities meet timelines and escalate challenges or deviations
Maintain compliance performance metrics and generate management and project-team status reports
Participate in continuous improvement initiatives
Create, administer, and summarize surveys

Requirements

What you’ll need

Bachelor's degree in life sciences, scientific, or engineering field
3+ years of general regulatory affairs experience and knowledge of the drug development process in the pharmaceutical industry
3 years of audit and inspection exposure and/or experience
Strong oral and written communication skills
Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, and other regulatory requirements
Experience working in regulatory affairs, healthcare, or a regulated environment
Experience with document management systems and regulatory compliance tools
Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook)
Ability to prioritize and work well in a fast-paced environment while multi-tasking and problem-solving
Preferred: Prior experience with new prescription drug/biologic applications (IND and/or NDA/BLA)
Preferred: Familiarity with electronic document management systems (EDMS)

Benefits

Comp & perks

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Paid time off
Life insurance
Additional benefit offerings in accordance with applicable plans
Some roles may be eligible for additional incentives, bonuses, or other compensation programs