Senior Regulatory Affairs Associate - Labeling ...

Take your career to the next level with an exciting opportunity at Parexel! We are looking for a dynamic Senior Regulatory Affairs Associate in Global Labeling Compliance and Analytics to become an integral part of our dedicated team. In this role, you will spearhead data-driven initiatives to ensure end-to-end (E2E) labeling compliance, utilizing your expertise in analytics and operations. Your contributions will enhance our oversight capabilities and support crucial compliance forums and audits. Key Responsibilities Data, Metrics & Analytics Leadership Design, manage, and report E2E labeling metrics and KPIs while identifying trends and improvement opportunities. Maintain and enhance the Global Labeling Monitoring & Evaluation Plan with new metrics for improved process health. Create engaging dashboards and analytical reports using Power BI, Excel, and pivot tables. Facilitate cross-functional alignment on metric definitions and reporting timelines. Develop presentation materials for Compliance Councils and governance forums, ensuring follow-up actions are tracked to closure. Compliance Governance & Forums Assist in Global Labeling Compliance E2E meetings and other governance activities, ensuring adherence to regulatory standards. Manage the scheduling of Pharmacovigilance aggregate reports until full transition is achieved. Provide insightful analytics to enhance regulatory and compliance decision-making processes. Data Oversight, Quality & Digital Enablement Ensure the accuracy and validity of data related to labeling implementation. Prepare materials for audits and inspections, addressing any data integrity concerns as needed. Drive digital enablement projects, including improvements in data models and process automation. Maintain high standards for data quality, integrity, and traceability throughout processes. Process Management & Change Support Support updates to processes (e.g., Veeva-related changes) and assess their impact across operations. Ensure alignment with Veeva COP workflows and manage system-related dependencies. Be cross-trained in key process management tasks to ensure operational continuity and backup coverage. Project & Cross-Functional Support Contribute to data-driven compliance reporting projects focused on data integrity. Provide analytic insights to various stakeholders across functions. Audit & Inspection Support Compile and review materials for audits, ensuring they meet accuracy and integrity standards. Support continuous improvement of audit processes to maintain an audit-ready state. Skills & Experience Required Bachelor's degree in Life Sciences, Pharmacy, Data Analytics, or a related field. Proven understanding of the E2E labeling process and its relation to Regulatory, Pharmacovigilance, and Manufacturing functions. Experience in compliance governance, KPI oversight, and audit support. Strong foundation in deviations, CAPA, audits, ALCOA+ principles, and process management. Hands-on familiarity with Veeva RIMS, TrackWise, QDocs, Documentum, and related regulatory data systems. Proficiency in advanced Excel (including pivot tables and analytics) and Power BI. Exceptional analytical skills with the ability to derive actionable insights from data. Commitment to high standards of data quality, integrity, and traceability. Excellent communication and organizational skills, with a knack for cross-functional collaboration. Experience interfacing with Senior Leadership and presenting to executive audiences. Project management experience or certification is a plus. Fluency in English, both written and spoken. Join us and make a difference!

Created: 2026-03-06