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About the Role: As 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 Responsibilities: Generates 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 development strategy.
Contributes from the labeling perspective/labeling environment to Clinical Study designs, protocols, Investigator Brochures and Briefing Books.
For the dCCDS/CCDS, leads the interactions with relevant Subject Matter Experts (SMEs) and stakeholders, such as Global Clinical Safety and Pharmacovigilance (GCSP), Global Clinical Development (GCD), Integral Regulatory Affairs (GRA) and Commercial Development and Operations (CDO).
For the USPI and EU SmPC, collaborate

📌 Senior Regulatory Affairs Consultant (España)
🏢 Parexel
📍 España