Senior Regulatory Affairs Associate Labelling Compliance
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Job Location:
Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.
We are seeking an experiencedSenior Regulatory Affairs Associateto 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 withVeeva 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
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
