**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
\#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.
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
\#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.