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

Parexel; Madrid; Híbrido; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A multinational pharmaceutical company is seeking an experienced European Labelling & Promotional Regulatory Specialist to manage EU Product Information and ensure compliance with regulatory requirements. The role involves leading readability testing and collaborating with cross-functional teams. The ideal candidate should have a degree in life sciences and strong knowledge of EU regulations. This position offers flexibility to work from home or the office in various European locations.

Formación

• Strong knowledge of EU regulatory requirements for product labelling and promotional materials.
• Excellent project management and organizational abilities.
• Outstanding written and verbal communication skills.

Responsabilidades

• Create, update and maintain EU Product Information.
• Lead Readability Testing processes including vendor selection and report submission.
• Monitor changes in EMA labelling requirements.

Conocimientos

Strong knowledge of EU regulatory requirements for product labelling and promotional materials

Excellent project management and organizational abilities

Outstanding written and verbal communication skills

Proven ability to work effectively in cross-functional teams

Experience with electronic content management systems and regulatory SOPs

Fluent in English, written and spoken

Educación

University degree in a life science discipline

Descripción del empleo

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.

The role can be home or office based in various European locations.

Key Responsibilities

• EU Product Information Management:
  

  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

  
  


• Operational Excellence:
  

  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

  
  


• Leadership & Collaboration:
  

  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