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Regulatory Affairs Professional - Labelling Compliance Analytics
Primary Location: Romania, Remote Job ID R0000039043 Category Regulatory Affairs Date Posted 02/24/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We are seeking a strategicSenior Regulatory Affairs Associate, Global Labeling Complianceto lead data and metrics-driven end-to-end (E2E) labeling compliance oversight. This pivotal role encompasses KPI design, analytics, reporting, data integrity, and governance support. The successful candidate will provide critical visibility into E2E labeling process health while supporting compliance forums, audits, and digital enablement initiatives. Cross-training in key process management responsibilities ensures backup coverage and operational continuity.
This is a client-facing role that can be based in the office or home.
Key Responsibilities
Data, Metrics & Analytics Leadership
Design, manage, and report E2E labeling metrics and KPIs; identify trends, risks, and improvement opportunities
Maintain the Global Labeling Monitoring & Evaluation Plan and develop new metrics for E2E process health
Build dashboards and analytics usingPower BI, Excel, and pivot tables
Lead cross-functional alignment on metric definitions, oversight expectations, and reporting cadence
Prepare slide decks for Compliance Councils and governance forums and track follow-up actions to closure
Compliance Governance & Forums
Support Global Labeling Compliance E2E Compliance Meetings, PSMF inputs, PCC, and other compliance governance activities
Manage Pharmacovigilance aggregate report scheduling until transition is complete
Provide analytics-based insights to strengthen regulatory and compliance decision-making
Data Oversight, Quality & Digital Enablement
Monitor, validate, and analyze data relevant to labeling implementation and oversight
Prepare audit/inspection evidence and escalate data integrity issues as needed
Support digital enablement initiatives, including data model improvements and process automation
Uphold standards for data quality, integrity, and traceability
Process Management & Change Support
Support process updates (e.g., Veeva-related changes) and evaluate downstream process impact
Align with Veeva COP workflows, system handoffs, and system-to-process dependencies
Cross-trained on key process management and Global Labeling training tasks for operational continuity and to provide backup coverage
Project & Cross-Functional Support
Contribute to data-driven and compliance reporting projects (e.g., GRA Data Cockpit, data integrity initiatives)
Provide analytic insights to upstream and downstream partners across functions
Audit & Inspection Support
Prepare and review data-driven audit materials, ensuring accuracy and data integrity
Support maintenance of an audit-ready state and continuous improvement of audit processes
Skills & Experience required for the role:
University degree in Life Sciences, Pharmacy, Data Analytics, or related field
Strong grasp of E2E labeling process and the interdependencies with Regulatory, Pharmacovigilance, and Manufacturing functions
Experience in compliance governance, KPI oversight, and supporting audits/inspections
Solid grounding in deviations, CAPA, audits, ALCOA+ principles, and process management
Hands-on experience withVeeva RIMS, TrackWise, QDocs, Documentumand regulatory data structures
Advanced Excel(pivot tables, formulas, analytics) andPower BI(dashboards, visualization) experience
Strong analytical capability with ability to translate data into clear insights and actionable CAPAs
High standards for data quality, integrity, and traceability
Excellent communication, organization, and cross-functional collaboration skills
Experience working with Senior Leadership and presenting to executive audiences
Project management certification or experience (preferred)
Fluent in English, written and spoken
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