regulatory affairs manager packaging.

Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.Point of contact for the management of all labelling/artwork requests that require market/regulatory approval in US and EU centralised procedure, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions.Coordinates and/or leads the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to existing packs, and mock-ups for regulatory submissions.Provide tactical and strategic guidance to product labeling teams regarding regulatory requirements for packaging component labelling • Understand industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling.Interpret US and EU labeling regulations and guidance, determining company impact and providing comments as appropriate.Contribute the regulatory labeling perspective in support of novel packaging design initiatives.Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.Originate precedent searches, create and maintain labeling comparisons, and assist in analysis of competitive labeling.Interact with Marketing Company colleagues regarding global artworks as appropriate.Process and prepare all US Final Printed Labeling and required EU specimens for submission.Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function.Liaise with relevant stakeholders as needed to resolve critical labeling issues.Represent functional expertise at relevant department meetings and relevant cross functional subteams. ...