Senior Regulatory Affairs Associate - Labeling Compliance Analytics
Parexel International, New York, New York, United States
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 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 elevate data integrity issues as neededSupport 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 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
#LI-LB1
#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
#J-18808-Ljbffr
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 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 elevate data integrity issues as neededSupport 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 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
#LI-LB1
#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
#J-18808-Ljbffr