At a Glance
- Tasks: Lead data-driven compliance oversight and analytics for labelling processes.
- Company: Join a forward-thinking company committed to innovation and excellence.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to collaborate across functions and present to leadership.
- Why this job: Make a real impact in regulatory affairs while working with cutting-edge data analytics.
- Qualifications: Degree in Life Sciences or related field; strong analytical and communication skills required.
The predicted salary is between 36000 - 60000 £ per year.
When our values align, there's no limit to what we can achieve. We are seeking a strategic Senior Regulatory Affairs Associate, Global Labeling Compliance to lead data and metrics-driven end-to-end (E2E) labeling compliance oversight. This pivotal role encompasses KPI design, analytics, reporting, data integrity, and governance support. The successful candidate will provide critical visibility into E2E labeling process health while supporting compliance forums, audits, and digital enablement initiatives. Cross-training in key process management responsibilities ensures backup coverage and operational continuity. This is a client-facing role that can be based in the office or home.
Key Responsibilities
- Data, Metrics & Analytics Leadership
- 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
- Compliance Governance & Forums
- 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
- Data Oversight, Quality & Digital Enablement
- 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
- Process Management & Change Support
- 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
- Project & Cross-Functional Support
- 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
- Audit & Inspection Support
- 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 & Experience required for the role:
- University 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
- Project management certification or experience (preferred)
- Fluent in English, written and spoken
Regulatory Affairs Professional - Labelling Compliance Analytics in Harrow employer: Parexel
At our company, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel in their roles. As a Regulatory Affairs Professional in Labelling Compliance Analytics, you will benefit from comprehensive training, cross-functional support, and opportunities for professional growth, all while working in a flexible environment that values work-life balance. Join us to be part of a team that is dedicated to making a meaningful impact in the life sciences sector, where your contributions will be recognised and valued.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Professional - Labelling Compliance Analytics in Harrow
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its values. Tailor your responses to show how your skills align with their needs, especially in areas like data analytics and compliance governance.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms to get comfortable with common questions. Focus on articulating your experience with E2E processes and data integrity.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Professional - Labelling Compliance Analytics in Harrow
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the role of Regulatory Affairs Professional. Highlight your experience in data analytics, compliance governance, and any relevant tools like Power BI or Excel.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your background makes you a perfect fit for our team. Don’t forget to mention your understanding of E2E labeling processes!
Showcase Your Analytical Skills:Since this role involves a lot of data and metrics, be sure to include examples of how you've used analytics to drive decisions in past roles. We love seeing how you can turn data into actionable insights!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets the attention it deserves. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at Parexel
✨Know Your Metrics
Make sure you understand the key performance indicators (KPIs) relevant to the role. Brush up on how to design and report metrics, as well as identify trends and risks. Being able to discuss your experience with data analytics tools like Power BI and Excel will show you're ready to hit the ground running.
✨Showcase Your Compliance Knowledge
Familiarise yourself with compliance governance and the E2E labeling process. Be prepared to discuss your experience with audits, inspections, and CAPA principles. This will demonstrate your understanding of the regulatory landscape and how it impacts labelling compliance.
✨Prepare for Cross-Functional Collaboration
Since this role involves working with various teams, think of examples where you've successfully collaborated across functions. Highlight your communication skills and how you've aligned different stakeholders on project goals or compliance expectations.
✨Bring Data-Driven Insights
Be ready to share how you've used data to drive decision-making in past roles. Prepare a few examples of how your analytical insights have led to improvements in processes or compliance outcomes. This will showcase your ability to translate data into actionable strategies.
