Parexel

Compensation

Full Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Exciting client partnership opportunity! We are seeking an experienced Senior Regulatory Affairs Associate to lead and contribute to end-to-end (E2E) labeling process management and oversight. This critical role ensures compliant, consistent labeling operations through deviation/CAPA governance, process execution, labeling systems stewardship, and audit readiness. The successful candidate will leverage supporting systems including Veeva RIMS, TrackWise, QDocs, and Documentum, while maintaining cross-training on KPI metrics and data-oversight activities for backup purposes. Key Responsibilities: Process Governance & Compliance Oversight Lead investigations and CAPA management for labeling-related deviations, driving root-cause analysis, trend identification, and cross-functional remediation Oversee E2E labeling process updates, escalation management, and process-to-system alignment Serve as CAPA Owner for process improvements and ensure clear communication of changes to stakeholders Support business partners and Safety Data Exchange Agreement obligations, ensuring roles, responsibilities, and clear process management are established to comply with contractual terms and conditions Labeling Systems Stewardship Act as Business Contact for Veeva RIMS, TrackWise, QDocs, and related systems Oversee system enhancements, issue resolution, and workflow maintenance Ensure effective process-to-system handoffs to support compliant and efficient labeling operations Audit & Inspection Readiness Lead preparation and coordination for audits and inspections, ensuring a "permanently inspection-ready" environment Maintain the Global Labeling Audit & Inspection Storyboard and develop supporting process flow maps Produce required system outputs and documentation, and support key SMEs and stakeholders during inspection interviews Process Improvement & Cross-Functional Alignment Serve as Veeva COP (Community of Practice) process expert and drive continuous improvement initiatives Ensure consistency of E2E labeling process handoffs across functions and regions Partner with Regulatory, Pharmacovigilance, Quality, and Manufacturing to address systemic issues and strengthen interdependencies Training & Regulatory Intelligence Develop and deliver Global Labeling training materials Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments Skills & Experience required for the role: University degree in a life science discipline Initial years of experience in regulatory affairs, with focus on labeling operations Deep understanding of E2E labeling processes and their interconnections with Regulatory, Pharmacovigilance, and Manufacturing Experience supporting business partner relationships Strong compliance expertise (deviations, CAPA, audits, process management, ALCOA+ principles) Proficiency with Veeva RIMS, TrackWise, QDocs, and Documentum Strong process thinking and understanding of how systems support regulatory workflows Excellent communication, organization, and cross-functional collaboration skills Ability to interpret and act on compliance-critical data with a strong continuous-improvement mindset Effective change-management capability across multiple functional areas Fluent in English, written and spoken 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™