Senior Regulatory Affairs Consultant - Labelling (home or office based)

Parexel; Uxbridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical services company in the UK is seeking an experienced European Labelling & Promotional Regulatory Specialist. The role includes managing EU Product Information, ensuring compliance with labelling regulations, and collaborating with cross-functional teams. Ideal candidates will have a life science degree and strong project management skills. Excellent English communication is essential.

Qualifications

• Strong knowledge of EU regulatory requirements for product labelling and promotional materials.
• Experience with electronic content management systems and regulatory SOPs.
• Outstanding written and verbal communication skills.

Responsibilities

• Create and maintain EU Product Information in line with regulations.
• Serve as key contact for EU Product Information with stakeholders.
• Lead readability testing processes and manage vendor agreements.

Skills

EU regulatory requirements knowledge

Project management

Communication skills

Cross-functional teamwork

Education

University degree in life science

Tools

Electronic content management systems

Job description

Overview

We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams. EU Product Information Management:

Responsibilities

• Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
• Serve as the key point of contact for EU Product Information for both internal and external stakeholders
• Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
• Deliver competitive labelling searches and contribute to TCLP for early development assets
• Ensure timely tracking and management of all EU Product Information in appropriate systems
• Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
• Coordinate Linguistic Review processes with LR Coordinator according to SOPs
• Communicate proactively with SPA for artwork and mock-up changes, participating in Change Control Processes
• Lead the Local Labelling Committee for creation, review and approval of EU Product Information
• Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials
• Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams
• Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements

Qualifications

• University degree in a life science discipline
• Strong knowledge of EU regulatory requirements for product labelling and promotional materials
• Experience with electronic content management systems and regulatory SOPs
• Excellent project management and organizational abilities
• Outstanding written and verbal communication skills
• Proven ability to work effectively in cross-functional teams
• Fluent in English, written and spoken