Senior Regulatory Affairs Associate - Labeling Compliance Analytics

Great opportunity to bring your regulatory labeling operations and analytics expertise to Parexel!

We are seeking a strategic Senior Regulatory Affairs Associate, Global Labeling Compliance Analytics professional to join a large, dedicated client partnership and 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.

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 using Power 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:

• Bachelor's 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 with Veeva RIMS, TrackWise, QDocs, Documentum and regulatory data structures
• Advanced Excel (pivot tables, formulas, analytics) and Power 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

#LI-LB1

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.