The Global Labeling Operations Lead is responsible for coordinating, managing and executing activities related to the approval and maintenance of printed labeling components (e.g., packaging mock-ups, patient information leaflets, container labeling). The role will also support the Global Labeling and Regulatory Strategy teams with various operational labeling activities, as well as help develop and / or improve internal processes.
This position will be within Global Regulatory Affairs (GRA) and will report to the Head of Global Labeling.
Key Responsibilities :
* Manage labeling and packaging artwork projects affecting multiple products to ensure timely delivery.
* Coordinate labeling artwork lifecycle management in collaboration with the Regulatory Strategy Leads and Labeling Operations Coordinators.
* Provide expertise to cross-functional teams and external vendors regarding regulatory requirements for the development of printed labeling components.
* Review and approve mock-ups and artworks to ensure compliance and timely delivery of print-ready packaging and labeling documents.
* Coordinate EU labeling readability testing and translation activities with vendor and oversee affiliate review of EU SmPC translations during linguistic review.
* Manage EU SmPC master documents in the Veeva Regulatory Information Management (Veeva RIM) system during product labeling life cycle.
* Collaborate with Global Strategic Labeling Leads to support the delivery of submission-ready EU and US labeling documents (e.g., EU QRD template formatting requirements, quality control activities).
* Serve as a liaison to external vendor regarding the creation, review and submission of US Structured Product Labeling (SPL) content.
* Support global labeling management improvement initiatives and participate in the development of SOPs, Work Instructions, and guidance documents.
Qualifications
Education / Learning Experience / Work Experience
* 5+ years of experience in Labeling Operations within the pharmaceutical industry.
* Experience in developing regulatory content for printed labeling components (e.g., carton and container) for EU (MAA / variations) and / or US (NDA / BLA) submissions; experience with additional regions / countries is a plus.
* Experience working in a global environment.
* Strong track record of leading projects and collaborating effectively in cross-functional teams.
Skills / Knowledge / Languages
* Strong knowledge of EU and / or US labeling regulations and guidance.
* Proficiency in working with electronic document management systems (e.g., Veeva), as well as the MS-Office Suite and Adobe Acrobat.
* Fluency in English, additional language skills are a plus.
* Ability to think strategically, communicate risks effectively, and recommend appropriate courses of action.
* Strong attention to detail.
* Excellent communication and negotiation skills.
* Comfortable working across geographies and in a culturally diverse organization with extensive cross-functional collaboration.
Personal Attributes
* Results driven and team-oriented attitude.
* Excellent organizational and time management skills.
* Hands-on approach and flexibility to succeed in a small-team environment within a growing organization.
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