[Hiring] (Senior) Regulatory Affairs Associate @Parexel

Role Description

We are seeking a Regulatory Affairs Associate or Senior Regulatory Affairs Associate to join our growing team! This is a client dedicated project, offering flexibility in working location across various European locations, either office or home based.

As the (Senior) Regulatory Affairs Associate, you will:

• Draft, maintain, and manage core labelling documentation, including CCDSs, SmPCs, package leaflets, prescribing information, and carton and container text.
• Ensure consistency across global and local labelling.
• Support lifecycle activities across multiple markets.
• Uphold high standards of document quality and compliance.

Qualifications

• University degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline.
• Previous experience in Regulatory Affairs, pharmaceutical labelling, technical authoring, or a related discipline.
• Knowledge of the structure, content, and maintenance of labelling documents.
• Experience supporting the preparation and maintenance of regulatory documentation.
• Understanding of GDP and quality management principles.
• Excellent communication, stakeholder management, and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.
• Fluent in English, both written and spoken.

Requirements

• Draft, edit, format, and maintain CCDSs and associated labelling documents using approved templates and standards.
• Prepare updates to product information documents, including SmPCs, package leaflets, prescribing information, and carton and container text.
• Ensure consistency and alignment of content across global and local labelling documentation.
• Apply regulatory and company guidelines to ensure documents meet quality and compliance expectations.
• Maintain accurate version histories and document traceability through effective change management.
• Track, review, and reconcile changes across submission versions using document comparison and review tools.
• Support implementation of CCDS updates and other labelling changes across multiple markets.
• Assist with regulatory variations, responses to Health Authority questions, and other lifecycle activities affecting product labelling.
• Contribute to labelling harmonisation initiatives and document remediation projects.
• Support the preparation of submission-ready labelling documentation within agreed timelines.
• Ensure documents are accurate, complete, and appropriately formatted before review and submission.
• Apply Good Documentation Practices (GDP) and internal quality standards throughout document development.
• Support continuous improvement of labelling templates, workflows, and authoring processes.

Company Description