Job Title

Regulatory Labeling Specialist The role of the Regulatory Labeling Specialist involves supporting the Client by assisting in the authoring, reviewing, and maintaining key labeling documents. This includes coordinating labeling updates across global markets, maintaining accurate version control, and ensuring compliance with regulatory requirements. Key Responsibilities: Assist in authorizing and editing Core Company Data Sheets (CCDS), US Prescribing Information (USPI), and other labeling documents. Review scientific, clinical, and regulatory information to support high-quality labeling content. Collaborate with cross-functional teams to ensure consistency between global labeling and regional/local market requirements. Coordinate labeling updates across global markets and maintain accurate version control. Support the preparation of labeling submission packages for regulatory authorities. Requirements: Bachelor's degree in Pharmacy, Life Sciences, or a related field. Minimum 5 years of experience in pharmaceutical regulatory affairs, labeling, or related scientific functions. Experience with global labeling standards, including CCDS, USPI, and EU SmPC; additional regional labels are a plus.