When our values align, there's no limit to what we can achieve.
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.
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
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.
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
