Job Description
Note: The job is a remote job and is open to candidates in USA. Parexel is a leading company in the regulatory affairs sector, and they are seeking a Senior Regulatory Affairs Associate to lead data and metrics-driven labeling compliance oversight. This role involves managing KPIs, analytics, and governance support while ensuring compliance and operational continuity.
- Responsibilities
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Fluent in English, written and spoken
- Project management certification or experience
- Company Overview
- Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. It was founded in 1983, and is headquartered in Raleigh, North Carolina, US, with a workforce of 10001+ employees. Its website is http://www.parexel.com.
- Company H1B Sponsorship
- Parexel has a track record of offering H1B sponsorships, with 33 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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