Senior Regulatory Affairs Consultant
Pubblicato il 03-09-2026 - Parexel in Italia
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 agevolazioni a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About the RoleAs a Labelling Strategy Regulatory Affairs Senior Consultant you will act as the principal labeling strategist within Global Regulatory Affairs (GRA). You will drive the development of Labeling strategies, the creation and maintenance of the development Company Core Data Sheet (dCCDS), the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio, as assigned, to ensure optimal alignment of the company position, labeling requirements,
and commercial opportunities.
As a seasoned expert, provides strategic input into the GRA Therapeutic Area Team from a labeling perspective. You will ensure that the company core product claims across products with the same active substance are globally aligned and leads the Global Labeling Committee assessment of proposed changes to the dCCDS/CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC.The role can be home or office based in various European locations.
Key ResponsibilitiesGenerates and maintains the development Company Core Data Sheet (dCCDS), the Company Core Data Sheet (CCDS), the USPI and the EU SmPC as assigned. Delivers the labeling strategy to early development activities to ensure consideration of labeling in claims development programs. Ensures that the labeling strategy is aligned with the overall product regulatory, registration and developme