Senior Regulatory Affairs Associate – Labelling Compliance
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Job Description
Senior Regulatory Affairs Associate leading end-to-end labeling process management at Parexel. Ensuring compliance and oversight through system stewardship and audit readiness.
Responsibilities:
- 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
- Drive continuous improvement initiatives and 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
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
- Retirement plans
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