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), Global Regulatory Affairs (GRA) and Commercial Development and Operations (CDO).
• For the USPI and EU SmPC, collaborates with the Regional Regulatory Therapeutic Area leads the review of these labels and respective, interaction with relevant SMEs.
• Ensures consistent communication to the Global Labeling Operation Managers, regions and countries regarding new and updated CCDSs for Therapeutic Area.
• Leads the assessment and, as necessary, Global Labeling Committee (GLC) review of proposed exceptions between the CCDS and the USPI and/or SmPC utilizing established departmental processes and maintaining compliance. Escalates differences and compliance issues to the Director, Global Labeling Strategy and/or labeling governance bodies as necessary.
• Represents Global Labeling on respective product Global Regulatory Affairs Strategy Teams (GRASTs), GRA Therapeutic Area (TA) teams and ensures that an effective communication pathway exists between the GRAST, TA teams and Global Labeling.
• Remains up to date with the global labeling requirements and expectations.
• Represents Global Labeling in internal and external meetings.
• Builds effective, cross-functional networks with GRA (regional and global) as well as across functions within R&D and Commercial Development.