As Regulatory Affairs Global Labeling Lead you will oversee all labelling activities for specified APIs (Active Pharmaceutical Ingredients) and collaborate with our client and IQVIA stakeholders, such as Global Labeling, PV, GRLs and the LOCs (Local Operating Companies) to ensure regulatory compliance.

Responsibilities

• Lead the timely development of content and management of core and regional labeling documents throughout the product lifecycle including the CCDS, EU SmPC, USPI and patient labels in accordance with the company and regulatory policies and procedures for the assigned products.
• Organize and lead the cross functional Labeling Working Group (LWG) meetings (including experts from RA, Clinical, Safety, Medical, Non-clinical, Reg CMC, etc.) to reach consensus on global labeling matters; assess impact of regional/local labeling changes on the CCDS for the assigned products; accurately capture, archive and communicate LWG decisions, and obtain endorsement by senior management.
• Coordinate with the Labeling Working Group and local/regional regulatory leads to manage local labeling deviations/exceptions for assigned products.
• Assist regional/local regulatory leads in developing labels for first-to-file submissions outside the EU and US, ensuring alignment with the CCDS and timely implementation of CCDS updates in local labels.
• Ensure labeling compliance is maintained within the Electronic Document Management system and the Regulatory Tracking System for the assigned products.
• Engage with Labelling Operations Coordinators (LOCs) as appropriate.
• Completes all labeling deliverables within the required timelines.
• Conducts quality control (QC) review for deliverables prepared by other GLLs.
• Manages Electronic Drug Registrations and Listing Systems (eDRLS) in US.

Do you meet the skills, experience, and educational requirements of the role?

• Regulatory labeling experience with the EMEA and North America region is a must.
• Extensive pharmaceutical Regulatory Affairs experience typically demonstrated by 5 or more years working in the pharmaceutical industry.
• Excellent written and verbal communication skills in English plus one more European language (Polish, Hungarian, German, Portuguese, Spanish, Romanian), with the ability to effectively communicate complex regulatory information to a variety of stakeholders.
• Pharmacy graduate or other life science degree.