Lilia Larnaout Email & Phone Number

Marlborough, Ma, Us

Boston, Ma, Us

I oversee the labeling in support of the immuno-oncology and HEME clinical trials, by interfacing with internal functional groups (QA, Operations, Supply Planning, External Manufacturing, Regulatory Affairs) as well as third-party vendors (print vendors, drug product packagers) during the development and approval process for product labeling to ensure common understanding of and execution of business objectives for labeling programs. This role requires the incumbent to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization.

London, England, Gb

CORREVIO acquired by Advanz Pharma Managing the artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new pack, or changes to existing packaging. Maintaining timelines and being responsible to report on progress of artwork changes. Ensuring all deadlines are met according to SOP and QA principles. Liaising with relevant departments and personnel such as QA, Supply Chain, CMC/Technical Services, Regulatory Affairs, Commercial, and Medical Affairs to ensure timely generation and approval of new or changed packaging artwork. Reviewing/streamlining the current artwork process, flow chart, SOPs, and bench-marking proofreading electronic tools.

Streamlined labeling processes and implemented key process improvement initiatives within Global Labeling. Worked with the Worldwide Regulatory Strategy team on the Core Label Text (CLT) and liaised with multidisciplinary teams to create a sustainable labeling solution for Wyeth Nutrition. Lead Nutrition Standards Board (NSB) meetings including reviews from point of view of Code Compliance and policies (Labeling, Promotional Material, and communications), ensuring minutes and follow-up of deliverables. Provided regulatory expertise and leadership in the development, management, and implementation of specific projects/products. Tracked BOH/labeling trends and presented analytical reports with findings and strategic recommendations for a better business decision.

New York, New York, Us

Managed and directed the development of Nutritional labeling artwork through Desktop Publishing, Proofreading, and Package Engineering groups within Packaging Design & Development. Responsible for the routing and approval of new or revised labeling artwork through the Global Labeling Division, site Quality Assurance, Medical, Regulatory, New Product Development, Marketing, Legal, Quality, and/or affiliates.

New York, New York, Us

Responsible for organizing and verifying drawings and all technical aspects of labeling. Coordinated projects such as equipment validation, evaluation of proofreading/editing processes and user requirements. Consulted, tested, and evaluated new proofreading/translation technologies and processes. Wrote Standards Operations Procedures, trained/tutored new Proofreaders, and interacted and developed strategies with international regulatory departments. Proofread pharmaceutical labeling (Biological/Vaccines, Over-the-Counter, Nutritional) and promotional material.

Wpwp, Business

Master'S, Multimedia

Bachelor'S, Communication