(Senior) Regulatory Affairs Associate - Labelling (home or office based)
Parexel · Romania
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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. You will ensure consistency across global and local labelling, support lifecycle activities across multiple markets, and uphold high standards of document quality and compliance.
Key Responsibilities
Regulatory Labelling Authoring
- 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.
Lifecycle and Regulatory Support
- 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.
Document Quality and Compliance
- 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.
Skills and Experience
- 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.