[Remote] Senior Regulatory Affairs Associate - Labeling Compliance Analytics

Note The job is a remote job and is open to candidates in USA. Parexel is a leading company in the regulatory affairs sector, and they are seeking a Senior Regulatory Affairs Associate to lead data and metrics-driven labeling compliance oversight. This role involves managing KPIs, analytics, and governance support while ensuring compliance and operational continuity. Responsibilities • Design, manage, and report E2E labeling metrics and KPIs; identify trends, risks, and improvement opportunities • Maintain the Global Labeling Monitoring & Evaluation Plan and develop new metrics for E2E process health • Build dashboards and analytics using Power BI, Excel, and pivot tables • Lead cross-functional alignment on metric definitions, oversight expectations, and reporting cadence • Prepare slide decks for Compliance Councils and governance forums and track follow-up actions to closure • Support Global Labeling Compliance E2E Compliance Meetings, PSMF inputs, PCC, and other compliance governance activities • Manage Pharmacovigilance aggregate report scheduling until transition is complete • Provide analytics-based insights to strengthen regulatory and compliance decision-making • Monitor, validate, and analyze data relevant to labeling implementation and oversight • Prepare audit/inspection evidence and escalate data integrity issues as needed • Support digital enablement initiatives, including data model improvements and process automation • Uphold standards for data quality, integrity, and traceability • Support process updates (e.g., Veeva-related changes) and evaluate downstream process impact • Align with Veeva COP workflows, system handoffs, and system-to-process dependencies • Cross-trained on key process management and Global Labeling training tasks for operational continuity and to provide backup coverage • Contribute to data-driven and compliance reporting projects (e.g., GRA Data Cockpit, data integrity initiatives) • Provide analytic insights to upstream and downstream partners across functions • Prepare and review data-driven audit materials, ensuring accuracy and data integrity • Support maintenance of an audit-ready state and continuous improvement of audit processes Skills • Bachelor's degree in Life Sciences, Pharmacy, Data Analytics, or related field • Strong grasp of E2E labeling process and the interdependencies with Regulatory, Pharmacovigilance, and Manufacturing functions • Experience in compliance governance, KPI oversight, and supporting audits/inspections • Solid grounding in deviations, CAPA, audits, ALCOA+ principles, and process management • Hands-on experience with Veeva RIMS, TrackWise, QDocs, Documentum and regulatory data structures • Advanced Excel (pivot tables, formulas, analytics) and Power BI (dashboards, visualization) experience • Strong analytical capability with ability to translate data into clear insights and actionable CAPAs • High standards for data quality, integrity, and traceability • Excellent communication, organization, and cross-functional collaboration skills • Experience working with Senior Leadership and presenting to executive audiences • Fluent in English, written and spoken • Project management certification or experience Company Overview • Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. It was founded in 1983, and is headquartered in Raleigh, North Carolina, US, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship • Parexel has a track record of offering H1B sponsorships, with 33 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply To this Job Apply To this Job

Back to blog

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...