Hours Per Day: 4.00
As part of the Global Labeling team within Global Regulatory Affairs, the candidate will participate to the achievement of:
Ensuring the compliance of the labeling documents,
Referencing of Corporate documents (i.e. CCDS, CCSI)
Contributing to labeling sections of Annual Reports in the US
Managing the activities related to the innovating cross-functional projects related to packaging and product information.
Manage the global labeling processes supporting the implementation of labeling changes at corporate and affiliate level.
Follow-up, update and implement of the global labeling procedures at corporate level and local level.
Perform the recurrent review of local labeling artwork.
Manage and improve the labeling tools needed to ensure labeling compliance.
Artwork functions, including:
Preparation of US labeling documents
Prepare markup/annotate, clean and SPL for submission to FDA
Prepare artwork markups and approve final artwork.
Proofread labeling, including SPL, (during all phases of submission and post-approval process) to ensure the labeling conforms to regulations and guidelines.
Coordinate updates of US product labeling for submission to HA, following Sanofi SOPs.
Recurrent Retrospective Labeling Review
Manage data owned by Global Labeling in the company database.
Ensure that the quality checks of the data owned by Global Labeling are complete and accurate and updated in a timely manner.
Clearly explain the regulatory requirements to other functions so that they are well-taken into account prior to project implementation.
5 to 10 yrs. of experience in pharmaceutical industry.
Experience in Regulatory Affairs,Artwork preferred.
Experience with proofreading tools (i.e. TVT, DocuProof)