Job Description
When our values align, there's no limit to what we can achieve.
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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.
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
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