Ensure adherence to regulatory standards and internal quality benchmarks by analyzing compliance data and preparing detailed reports. Collaborate with various departments to maintain and improve compliance and quality standards effectively.

• Act as a labeling strategist within Global Regulatory Affairs (GRA) • Drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio • Ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area • Manage the exception process between the CCDS and the USPI and EU SmPC • Collaborate with relevant Subject Matter Experts and stakeholders • Ensure consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products • Maintain compliance by leading the assessment and Global Labeling Committee review of proposed exceptions • Represent Global Labeling on respective product Global Regulatory Affairs Strategy Teams

• Managing labeling ensuring compliance with regulatory requirements • Support marketing authorization submissions and lifecycle management • Coordinate artwork development and version control • Collaborate with cross-functional teams for labeling accuracy

• Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs • Prepare and review CMC packages • Support GMP submissions • Manage change control assessments • Ensure compliance with regulatory requirements across multiple regions • Act as the main GRA point of contact for LRAs and other stakeholders • Author Administrative and CMC regulatory documents/deliverables • Collaborate with project SMEs and client stakeholders to prepare submission packages