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

European Labelling & Promotional Regulatory Specialist

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.

About the Role

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 :

Leadership & Collaboration :

Qualifications & Skills Required for the Role :