Senior Regulatory Affairs Associate – Labeling Compliance
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Job Level
About the role
- 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
- 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
- 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
- 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
- Develop and deliver Global Labeling training materials
- Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments
Requirements
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CAPA managementroot-cause analysistrend identificationprocess improvementsE2E labeling processescompliance expertisechange managementregulatory workflowscontinuous improvementtraining material development
Soft Skills
communicationorganizationcross-functional collaborationprocess thinkingstakeholder managementproblem-solvinginterpersonal skillsadaptabilityattention to detailanalytical thinking